1

BBA Domain Specialization Project Report

On
“TITLE OF THE PROJECT”

Submitted in partial fulfillment of the requirements for the

Two Year DIPLOMA in __________

Submitted By: Under the Guidance of:

Nehal Jain Mentor(s) CA Aakansha arora mam
Enrollment No: 169359150 Designation
Batch:2016-2019
 2

CERTIFICATE OF ORIGINALITY

I hereby declare that this university Project is my own work and that, to the best of my
knowledge and belief, it reproduces no material previously published or written that has
been accepted for the award of any other degree of diploma, except where due
acknowledgement has been made in the text.

(NEHAL JAIN)
Enrollment No.
Date:
 3

INDEX
SR.NO PARTICULARS PAGE NO.
INTRODUCTION 5-55
1 1.INTRODUCTION
TO THE TOPIC
2.COMPANY
PROFILE
3.SCOPE AND
IMPORTANCE OF
THE STUDY
4.LITERATURE
REVIEW

RESEARCH 56-77
2 METHODOLOGY
1.OBJECTIVES OF
THE STUDY
2.RESEARCH
DESIGN
a.SAMPLE DESIGN
b.SOURCES OF
DATA COLLECTION
 4
ANALYSIS AND 77-80
3 FINDINGS
1.ANALYSIS OF DATA
2.SUMMARY OF
FINDINGS
SUMMARY AND 81-82
4 CONCLUSIONS
CONCLUSION AND
RECOMMENDATIONS
BIBLIOGRAPHY 83
5
 5

COMPANY PROFILE
Established in 1973, Micro Labs is a fully integrated
pharmaceutical company, present across the entire
pharmaceutical value chain from Research and
Development, Active Pharmaceutical Ingredients,
Finished Formulations to Marketing and Distribution in
India and overseas.
• Micro is a privately held company, founded by Late
Mr. G. C. Surana, now under the leadership of Mr.
Dilip Surana & Mr. Anand Surana
• Strong Focus in India, with presence in over 40
countries and 3300 product registrations at various
stages
• Ranked amongst top 19 in India with a market share
of 1.95% as per AIOCD-AWACS December 2017
• Leading positions in select therapeutic areas like
Cardiology, Diabetology, Ophthalmology,
Dermatology, Pain / Analgesics etc.
• PAN India sales presence with a large and over 5800
experienced field force
 6
• State–of–the–art manufacturing facilities approved
by USFDA, UK-MHRA, etc
• 3 R&D centres with capabilities of ANDAs, DMFs and
NDDS

DOMESTIC OPERATIONS
• Pioneer in specialty marketing, with expert teams
that are built around the specialty customer
• Contributing significantly to the healthcare needs of
domestic market for over 3 decades
• Growing at an annualcompounded growth rate of
14%
• Currently marketing is structured into 19 divisions
each of which is customized to deliver a
promotionalmessage to a certain class of specialty
customer
• Our 5600 medical representatives cover over
250,000 doctors & 180,000 pharmacies
 7

GLOBAL FOOTPRINT
• Micro is well poised to achieve in the medium term
status “BIG GENERIC COMPANY” in the global
pharmaceutical space
• Building critical mass in existing markets &
developing business in new market like USA, East
Europe, North Africa and South & Central America
• The group has presence in over 40 countries, with
ground level operations in 15 countries, exporting all
major dosages in every therapeutic segment
Own marketing, regulatory & sales operations in the
following geographies:
• Asia – South East – Thailand, Myanmar, Cambodia,
Vietnam
Far East – Taiwan, Srilanka, Nepal, Philippines,
Malaysia, Indonesia, Singapore
Middle East – Yemen, Iraq, Sudan, UAE
• Europe – CIS – Azerbaijan, Russia, Kazakhstan,
Ukraine, Moldova, Belarus, E.U.
• Africa – South Africa
West Africa – Senegal, Nigeria, Ivory coast,Cameroon
 8
East Africa – Kenya, Uganda, Tanzania
North Africa – Algeria, Libya
• South & CentralAmerica – Mexico, Guatemala,
Panama, Dominican Republic, Peru

MANUFACTURING FACILITIES
Total No. of Plants: 13
• 3 Sites in Hosur , Tamil Nadu
• 7 Sites in & around Bangalore
• 1 Site in Pondicherry
• 1 Site in Goa
• 1 site in Sikkim

R&D CAPIBILITIES
The company is committed to doing world-class
research that develops bio-equivalent generics. A
focused effort in defined areas and a lasting interest in
new technology are key features of our efforts to
develop NDDS & innovative combination products in
the medium - long term.
 9
• Micro R&D centre is an integrated set up with 3
research centers located in Bangalore & Mumbai.
• Analytical facilities range from compound
identification to bio-analytical capabilities consisting
of all modern equipments.
• The research team comprises of 300 Scientists /
Pharmacists / Analysts / Chemists Microbiologists
engaged in product & analytical development
 10

Formulation Development Expertise

Facility is equipped to develop following dosage
forms:
• Tablets :Conventional, Extended Release, Delayed
Release, Once- a-Day, Chewable, Dispersible,
Orodispersible and Gastroretentive.
 11
• Capsules: Hard gelatin capsules with Powder,
Compacts, Pellets and Tablets
• Liquids : Suspensions, Emulsions and Solutions
• Powders:Dry powder for Reconstitution
• Pellets: Uncoated, Film coated and Enteric coated
pellets
• Semi-solids: Creams, Ointments, Aqueous and
Hydro-alcoholic Gels
• Aerosols:Dry powders for inhalation and Nasal
Sprays
• Ophthalmics: Eye drop solution, Suspensions
• Injectables:Dry powder and Liquid Injectables API
R&D Capabilities
• Focus on Development API’s off patent between
2013-19
• Strict Compliance IPR / Non-infringing roots.
• Infrastructure includes facility for scale-up &
validation.
• Handling complex chemistries.
• Regulatory complaint development & scale-up.
• File EU-DMF / E-COS / US-DMF
• 8 Molecules under development
 12

Regulatory Affairs
Well-trained Regulatory Affairs team in India for
preparing technical dossiers to support product
registration

RA

SEMI
REGULATED
REGULATED
MARKETS
MARKETS
Our regulatory team is also placed in various offices
globally such as Philippines, Vietnam, Russia, CIS, UK,
Mexico etc. This helps in better understanding and
 13
compliance of local regulatory requirements in
respective region.

IPR and Clinical Dept

• Dedicated team consisting of Registered Patent
agents, & External consultants with strong
pharmaceutical expertise help in bringing new
products (and processes of course) from bench to
bed site
• IPR Cell Mandate
– Infringement Clearance Certificate (ICC)
– Global Technology Status Watch
– IP capital generation for the company
– Capture of Technology in frontier areas
– R&D funding
– IPR compliant Data Management/Protection
• Clinical Dept
 14
• In-house clinical dept to support regulated and semi
regulated markets
• Provides inputs on:-
 Review/approval of Bioequivalence protocols
 Study monitoring to ensure adherence to the
approved protocol and GCP compliance
 Bioequivalence reports review
 Identification/audit of CRO’s
 Expert report on BE studies for CTD module-V
 Clinical and Non-clinical expert reports for regulated
markets as per CTD format.
Co-ordination with RA authorities (for clinical) world
wide.

Future focus
Strategic alliances from…
Out-licensing projects from our development
pipeline
 15
Joint product development / Contract Research with
supply of finished products
Early launch through licensing / Royalty / Profit
Share
Contract manufacturing in regulated markets
In-licensing products / authorized generics for global
sales
 16

Top 10 countries in the prevalence of Diabetes

Top 3 countries & the numbers

People with Diabetes
 17
(Cr)
Rank Country 2000 2030
1 India 3.2 7
2 China 2.1 4.2
3 USA 1.8 3.0

Diabetes – The Disease

Drives The Market
 Ageing Indian Population leading to
- Increased Life span
- Presentation of Life style Diseases
- Exponential increase in Diabetes
- presentation of severe age related complications
• A handful of companies namely Aventis,
Nicholas Piramal, Micro, USV, Sun, Panacea
 18
Biotech, Intas ,Glenmark and Aristo will encash
the huge market.
Unlike cardiology, the Rx segment will be GP’s,
Cardiologists, Physicians, Surgeons and other Doctors

The Origin
Diabetes-Siphon (Greek)
means melting down of the flesh and limbs into urine
Mellitus - Sweet
sweet urine being symptom of disease.
 19

Diabetes
Diabetes is a hormonal disorder where the body isn’t
able to properly use/produce a hormone called insulin
which helps break glucose in our food to convert it to
energy.
High levels of unregulated glucose in the bloodstream
can damage the kidneys, eyes, nerves, even cause
cardiac arrests. Depending on the inability to use or
produce insulin, diabetes has been divided into two
types:
Type I and Type II.
There is also another condition called prediabetes,
where an individual’s blood sugar levels are higher than
the normal level, however, these raised levels are not
enough to diagnose a patient with diabetes.
 20
However, a person at this stage is at risk of developing
diabetes in due course.

TYPE 1 Diabetes
Type 1 diabetes is chronic (lifelong)disease that occurs
when the pancreas does not produce enough insulin to
properly control blood sugar levels.

Causes type 1 Diabetes

The body’s own immune system attacks and destroys
beta cells in the pancreas that are responsible for
creating the hormone insulin.

Type 2 diabetes
Type 2 diabetes formerly called non-insulin dependent
diabetes is a disorder that is characterized by high blood
glucose in the context of insulin resistance and relative
insulin deficiency.

Causes type 2 diabetes

 21
Type 2 diabetes occur when the pancreas does not make
enough insulin or the cells of the body become resistence
to insulin.

Causes of diabetes
While Type I and Type II Diabetes look similar, their
causes are their differentiating points.
• Type I diabetes is caused by an autoimmune
disorder where the immune system mistakes normal
body functions as hostile.
Type II diabetes is caused because the body develops a
resistance to insulin and therefore doesn’t respond
adequately to the hormone.

Symptoms
• While the two types of diabetes have some
common symptoms, they also display some
unique symptoms, which help in differentiating
the two.
 22
• There is also the fact that people with type II
diabetes, develop symptoms over a period of
years while the development rate of type I
diabetes is very fast in comparison to the former.
• It should also be noted that if detected in time,
type II diabetes can be prevented, but type I
diabetes cannot be prevented.
• Some of the symptoms are:Polyuria, Polydipsia,
Glycosuria, Polyphagia, Asthenia, Blurring of
vision, Loss of weight etc.

Diabetes: Data At a Glance -

Diabetes along with Heart Disease is the most
common chronic disease in India.
Thus, it is not really surprising that by 2008 India
held 21% of the world’s share of diabetic patients
and that by 2017 with 70 million registered cases
of diabetes, India because of the 2nd country in
the world with the most number of diabetic
patients. however, may come as a little surprise
that diabetes is the underlying cause behind 50%
adult deaths and that the age range of diabetic
 23
patients is the largest with patients being as young
as 20 years to as old as 79 years.
The projected data for 2037 states that the
number of diabetic patients in India would rise to
120 million

B.E.A.T DIABETES
BE PHYSICAL ACTIVE.
EAT HEALTHY DIET
ABCS ( KNOW AND CONTROL) -
AIC,BLOODPRESSURE CHOLESTROL
,SMOKING
 TAKE YOUR MEDICATION

Treatment for Diabetes

Successful treatment makes all the difference to
long-term health, and achieving balanced diabetes
treatment can be the key to living with both type
1and type 2 diabetes.
 24
Treatment varies for each individual, not simply on
the type of diabetes that they have, but also more
individual-specific diabetic treatment differences.
Treating your diabetes
Your diabetes treatment and management
strategy should be agreed between you and your
health care team.
The aim of diabetes treatment is to keep, within
reason, blood glucose levels as near to normal as
possible. Training in self management of diabetes
forms an essential part of diabetes management.
Treatment should be agreed on an individual basis
and address medical, psychosocial and lifestyle .

ALT TREATMENT
Balanced diabetes treatments
A variety of different factors have a role to play in
treating diabetes, but the importance of balanced,
co-ordinated diabetes treatment for all diabetics
cannot be underestimated.
Regular and successful treatment decreases the risk
of each patient developing diabetes complications.
 25
The basics of diabetes treatment are broken down
into each diabetic type below.
Treatment of Type 1 diabetes
Type 1 diabetes treatment is a daily task. Lack
of insulin production by the pancreas makes Type 1
diabetes is particularly difficult to control.
Treatment requires a strict regimen that typically
includes a carefully calculated diet, planned physical
activity, multiple daily insulin injections and
home blood glucose testing a number of times per
day.
Treatment of Type 2 diabetes
Treatment typically includes diet control, exercise,
home blood glucose testing, and in some cases, oral
medication and/or insulin. Approximately 40% of
people with type 2 diabetes require insulin
injections.

Devices used for DIABETES

FreeStyle Libre
 26
Available to diabetics in the UK, FreeStyle Libre consists
of a small sensor patch that is placed on the arm and
can be worn for up to 14 days. Developed by Abbott
Diabetes Care, the patch measures glucose levels in the
interstitial fluid between the cells right under the skin.
Although the measurements are not as accurate as
using a blood test, the device allows patients to monitor
their glucose levels continuously and wirelessly, either
using a reading device or downloading an app on their
phones.

GlucoTrack
Developed by Integrity Applications in Israel,GlucoTrack
can measure blood sugar levels through a combination
of ultrasonic, electromagnetic and thermal waves.
To provide a readout, the sensor is clipped on the ear.
The device is indicated for adults with type 2 diabetes
and is currently approved in Europe, where the
company has just recently started to commercialize the
glucose monitor.

Eversense
 27
Developed by Senseonics, Eversense is a subcutaneous
implant that can last for up to 3 months. The device can
measure glucose in the interstitial fluid under the skin of
the arm by using a polymer that fluoresces in response to
the levels of glucose. The data is then sent to transmitter
that displays the glucose levels in real time.
The device recently received FDA approval and the
company struck a deal with Roche to distribute the
sensor.

Diet and preventing type 2 diabetes

Diet is the most important part of lifestyle change. The
adage that you can’t outrun a bad diet is true.
It is much easier to lose weight on a good diet even if you
are struggling to do exercise, than it is through exercise if
you’re eating a poor diet.
Effective diets to prevent type 2 diabetes are those that
do not cause your body to produce a lot of insulin.
Carbohydrate has the biggest demand on insulin and so
 28
any diet that helps reduce carbohydrate intake will help
towards reducing your risk of type 2 diabetes.
Cutting out sugary food and drink and refined grains such
as white bread and white rice is a good first step.
Modern research has shown that low-fat diets are not as
healthy as they were once believed to be. It is more
important to avoid processed food rather than trying to
avoid fat in foods such as dairy.
Aim to have a balanced diet by basing meals around
vegetables and include healthy sources of fat such as
unsalted tree nuts (walnuts, almonds, hazelnuts), olive
oil, avocado, oily fish, meat and full fat dairy.

Overview Prevention of diabetes

When people talk about prevention of diabetes, it is
usually about preventing type 2 diabetes. In the majority
of cases, type 2 diabetes is brought on by lifestyle factors
which can often be prevented.
These include an unbalanced diet, lack of activity, lack of
sleep, stress, smoking and alcohol.
 29
By making lifestyles changes, you can decrease your risk
of developing type 2 diabetes.
Type 2 diabetes prevention overview
Leading doctors and researchers point to excessive levels
of insulin as the likely reason why insulin resistance and
type 2 diabetes develops.
Strategies such as low-carb diets and exercise help to
reduce levels of insulin and are therefore effective for
preventing type 2 diabetes from developing.
There are a number of risk factors for diabetes, some of
which are preventable, such as weight gain around the
middle (central obesity), high cholesterol/triglyceride
levels and high blood pressure.
Losing weight, adopting more activity into your day,
stopping smoking and reducing alcohol intake can also
help towards lowering the risk of developing type 2
diabetes mellitus and improving your all-round healt
30
31
32
33
34
35
36
 37

Screening for Diabetes

• Laboratory Blood Glucose Test
The chosen method for determining glucose
concentrations is the Glucose Oxidase Method.
This gives a linear relationship between the
 38
concentration and the spectoral absorption at a
wavelength of 500nm.
In the primary reaction, glucose oxidase oxidizes
-D-glucose to gluconic acid and hydrogen
peroxide.
The hydrogen peroxide is then consumed by a
horseradish peroxidase-reduced dye indicator
reaction, in which the oxidized dye is colored
and can be monitored using a
spectrophotometer (Byrnes, 1995).

HbA1c test
Glycosylated Hemoglobin Test (HbAlc)
• The HbAlc test measures blood glucose content
that gets bound to the hemoglobin.
• The hemoglobin comes out of Red Blood cells when
they ‘die’ after completing 120 days of a fixed life-
span
 39
• Hence, the glucose component bound to
hemoglobin reflects the patient’s glucose levels in
the last 3 to 4 months.

HbA1c % equivalent in mg/dl

Nathan Formula
HbA1c % = mg/dl +86 / 33.3
Suppose a patient has a blood glucose level of 150
mg/dl then his HbA1c is ---- 150 +86 / 33.3 = 7%.

Blood glucose levels ADA

(American Diabetes Association)
NORMAL
FBG 70 - 110 mg /dl
PPBG 110 - 140 mg /dl
HbA1c 4 -6 %
DIABETIC
 40
FBG > 126 mg /dl
PPBG > 200 mg /dl
HbA1c > 7%

Classification of Diabetes
Type 1 (IDDM) Type 2 (NIDDM)
• < 5% of cases 90 % of cases
• ß cells are dead Malfunctioning of ß cells /
or peripheral cells
• Insulin not present Insulin is low / normal/
/ negligible even high

Causes of Type-2 Diabetes

Insulin Deficiency(ID)
Insulin Resistance(IR)
 41

Insulin Deficiency(ID)
• Malfunctioning of ß cells
• Quantity of insulin secreted is less
• Insulin is not secreted in biphasic manner

Insulin Resistance(IR)
•A mutant receptor which is unable to recognize
and bind insulin effectively.
•The presence of anti-insulin antibodies which
bind insulin and prevent its binding to receptors.
•The presence of anti-insulin receptor
antibodies which attach to the receptor and
prevent insulin binding to the receptor.
•A mutation in the tyrosine kinase region of the
receptor which prevents signal transduction.
•A mutation in one of the proteins in the signal
transduction pathway.
 42

Insulin
(Meaning Island in Latin.
This is how islets looked in pancreas)
• Major hormonal regulator of glucose metabolism.
• First isolated by Banting and Best in 1922 for the
treatment of the so-called“Sugar disease”
• Secreted by beta cells present in the islets of
langerhans.
• Regulates carbohydrate , fats & protein metabolism

Pancreas
A lobulated gland functioning as an exocrine and
endocrine (Secrete hormone directly into blood
stream) organ.
 43
The exocrine portion consists of Acini which
secretes pancreatic juice which passes through
common bile duct into the duodenum.
The endocrine portion consists of Islets of
langerhans cosisting of alpha, beta and delta
cells which secretes glucagon, insulin and
somatostatin respectively.

Islets of Langerhans in Pancreas

Alpha cells: Form 15-20% of Islets and produce
Glucagon – Stimulates the release of glucose
into blood stream.
Beta cells: Form 70-80% of Islet cells and
produce Insulin – Is essential for body’s cells use
of glucose as energy source. Facilitates the
movement of glucose away from blood stream.
Delta cells: Form about 5% of the Islet cells and
produce Somatostatin – Inhibits the release of
insulin and gastrin.
 44

Insulin
secretion triggered by
• hyperglycaemia
• vagal stimulation
• leucine / arginine
• free fatty acids & ketone bodies
• sulphonylurea drugs
secretion enhanced by
• glucagon like peptide (A hormone that stimulates
beta cells to secrete insulin)
secretion inhibited by
• catecholamines
• somatostatin

Insulin –
Action at cellular level
 45
Binds to cell-surface insulin receptor
Activates a protein kinase (Tyrosine Kinase)
Leads to downstream intracellular insulin
signalling
Biosynthetic processes of GLUT-4
glucose uptake enhanced

Biphasic Insulin release pattern

Counter-regulatory hormones for Insulin
Released in response to hypoglycaemia.
glucagon
• from pancreatic islet  cells
• acts on liver
•  gluconeogenesis & glycogenolysis
adrenaline
• acts on liver muscle and fat cells
•  glycogenolysis, lipolysis
 46
cortisol
• acts on liver, muscle and fat
•  gluconeogenesis, protein breakdown
•  muscle glucose uptake growth hormone
• from anterior pituitary
•  lipolysis
•  muscle glucose
uptake

Endocrine causes of
diabetes mellitus
(Very common)
• no insulin production
• insufficient insulin production
• tissue insensitivity to insulin
(Very rare)
 47
• increased circulating levels of counterregulatory
hormones
• excessive growth hormone (acromegaly)
• excessive catecholamines
• excessive cortisol (Cushing’s syndrome)

Diabetes and its Complications

Long term complications of Diabetes
Macrovascular diseases
 Heart disease & stroke
 Lower limb amputation
Microvascular diseases
 Diabetic nephropathy Kidneys are enlarged
Presence of microalbuminurea
Macroproteinurea
Gradual drop in kidney function
Kidney failure & death
 48
 Diabetic retinopathy Increased capillary
permeability
Occlusion of retinal capillaries
Haemorrhage into innerretinal areas occurs
Blindness
Diabetic Neuropathy
Diabetic retinopathy
• leading cause of blindness in working ages in UK
• 95% of diabetic subjects show some
by 15 years after onset
• risk factors:
age
diabetes duration
high blood glucose levels
high blood pressure
genetics
• may progress rapidly during pregnancy
 49

Diabetic nephropathy
• Affects 25% of type 1 and type 2 diabetes patients
• Risk factors similar to those for retinopathy
• Is a progressive condition leading to renal failure
• Characterised by proteinuria and high blood
pressure

Diabetic neuropathy
• Affects type 1 and type 2 diabetes patients similarly
• Risk factors similar to those for retinopathy
• may lead to
• loss of sensation in feet
• foot ulceration
• erectile dysfunction
• gastroparesis and vomiting
• postural hypotension
 50
In Type-2 Diabetes
After a period of time

Insulin Deficiency

Insulin Resistance
PROGRESSIVE BETA CELL FAILURE (UKPDS)
 51

Management of Type-2 Diabetes

Diet
Exercise
OHA ( Oral Hypoglycemic Agents )
Monotherapy
Increase the dose of OHAs
Combination of OHAs

BIDS
Insulin injections

Action of OHA s
• Sulphonylureas Pancreatic - beta-cell ID
• Biguanides Extra-pancreatic IR
esp: hepatic cells
 52
• Glitazone Extra-pancreatic IR
esp: peripheral cells
• Glinides Pancreatic - B - cells ID
• Alpha - glucosidase inhibitors Gut
• DPP IV Inhibitors Gut

Classification of OHAs
1. Sulphonylureas Glibenclamide , Glipizide ,
Gliclazide , Glimepiride
2. Biguanides Metformin

3. Glitazone Pioglitazone

4. Glinides Repaglinide , Nateglinide

5. Alpha - glucosidase
Inhibitors Acarbose, Miglitol, Voglibose
 53
6. DPP – IV inhibitors Sitagliptin, Vildagliptin &
Saxagliptin,Teneligliptin

SULPHONYLUREAS
 They were first introduced in 1956
 Are classified as
- first generation
- second generation
 Best administered 15 -30 minutes before food
 No advantage to switch within the same generation
of SU or to combine 2 Sus

SULPHONYLUREAS
Mechanism of action
 Pancreas
- stimulate insulin release
 54
 Extra-pancreatic effect
- improve insulin sensivity?
- a postulation !
# not effective in type I diabetes

BIGUANIDES
Mechanism ofaction
 Is unclear
?
- reduce hepatic glucose production
- reduce gastrointestinal absorption ofglucose
- increase insulin-stimulated glucose transport inmuscle
- increase in insulin receptor binding

ORAL AGENTS
CONTRAINDICATIONS
 55
 Type I Diabetes
 Pregnancy and Lactation
 Concurrent diseases
- hepatic, renal, or infections
 Primary failure
 Secondary failure
 56

4. RESEARCH METHODOLOGY

Researchmethodsarethetechniques,researchersusetostructureastudy
andtogatherandanalyzeinformationrelevanttothequestion.Methodologyrefersto
thephilosophyonwhichresearchisbased.Thisincludestheassumptionsandvalues
thatserveasthetoolsortechniqueusedtocollectdata.[153]

Research methodology is a way to systematically solve the research

problems. It may be understood as a science of studying how research is done
scientifically. It is necessary for the researcher to know not only the research
methodsbutalsothemethodology.Theresearchmethodologyhasmanydimensions and
research methods do constitute a part of the research methods.Research methodology is
a significant part of any study, which enables the researcher to project the research
undertaken. Research methodology is the systematic way to carry out an academic study
and research in flawless manner. The methodology
enablestheresearchertoprojectablueprintofthedetails,Data,approach.Analysis and
findings of research undertaken.[154]

The present study was conducted to assess the effectiveness of yoga on

clinicalparametersofGestationalDiabetesMellitusamongMotherswithGestational
diabetesMellitusatGovernmenthospital,Tambaram,Chennai.Thischapterincludes aspects
like Research approach, Research design, Variables in the study, Setting
Population,Sample,Samplesizeanditscalculation,Samplingtechnique,Criteriafor sample
selection, Development, description of the tool and scoring interpretations
andDescriptionofintervention,Interventionfidelity,Pilotstudy,Validityofthetool,
Reliability, Ethical consideration, Method of datacollection and Plan for Data analysis
and Drop out and itsanalysis.
 57

RESEARCHAPPROACH

A quantitative research approach –Evaluative in nature was adopted

to accomplish the main objective of this study. The primary objective of this study
wastoassesstheeffectivenessofyogaonclinicalparametersofGestationalDiabetes
Mellitus among mothers with Gestational DiabetesMellitus.

RESEARCHDESIGN

TheresearchdesignimpliedforthisstudywasQuasiexperimental–preandposttest
design.[155-158]

Group pre Interv Post Reinfor Post Reinfor post Reinfor Post
Test ention Test cement Test cement Test cement Test
of of of
Interve Interve Interve
ntion ntion ntion
Study
01 X 02 X 03 X 04 X 05
Group
Control
01 02 03 04 05
Group
above
Weeks of
24 28 32 36 36
Gestation
weeks
01- Pretest level of clinical parameters of Gestational DiabetesMellitus

X- YogawhichincludesYogicpositions(SukshmaVyayamas),pranayamaand

Dhyanam (Meditation) from 24th week to tilldelivery.

02-04–PosttestlevelofclinicalparametersofGestationalDiabetesMellitusand

Level of satisfaction onYoga

O5 - Maternal, Fetal and Neonataloutcome

 58

VARIABLES

IndependentVariable

In this research study the independent variable was the Yoga which
includes Yogic positions (Sukshma Vyayamas), Nadishodana pranayama and
Dhyanam (Meditation) for antenatal mothers with Gestational Diabetes mellitus

DependentVariable

In this research study the dependent variable were Clinical parameters of

Gestational Diabetes Mellitus

DemographicVariables

Consisted of Age, Religion, Type of family, Educational status, Work

pattern, Income and Type of Marriage.

ObstetricalVariables

Past obstetricalhistory

The variables were diagnosis of Gestational Diabetes Mellitus at previous

pregnancy in gestational weeks, treatment of gestational diabetes at previous
pregnancy, previous history of type of delivery, weight of the previous child, effect
of diabetes in previous pregnancy, previous history of children with congenital
abnormalities and family history of diabetes.

Present Obstetricalhistory

The variables were height, gravida, parity, abortions, still birth, death,
number of children and medication taken during pregnancy.

Maternal, Fetal and Neonatal OutcomeVariables

Maternal outcome variables: Weeks of gestation at Delivery,

Mode of Delivery, Complications duringlabour.
 59

Fetal Outcome variables: Congenital malformation,

Fetalmacrosomia, Intra
uterinegrowthrestriction,Intrauterinefetaldeath,CombinedCo
mplications and No Complications.

Neonataloutcomevariables:APGARscoreat1stminute,5thminut
eandBirth weight of the baby and Neonatalcomplications.

ExtraneousVariables

In this study the extraneous variables were diet pattern, Mass media

SETTING

The research study was conducted at Government General Hospital,

Tambaram taluk. It is one of the CEmONC(Comprehensive Emergency Obstetric
andNeonatalcareCentre)centerandthemodelhospitaloftheKancheepuramdistrict
which has got 3 days per week as a Antenatal day. The OPD has got 800-900
antenatalcases permonth andthenewantenatalcaseswere 150-180permonthand the
Mother with Gestational Diabetes Mellitus cases were 20-30 per month. The
Organizational climate of this institution was conducive to conduct this research
study.ThePhysicalfacilitiesneededtoimplementtheinterventionwereavailablein
thehospitalconferencehallatfirstfloorandit wasspaciousenoughtocarryoutthe
intervention.TheantenatalOutpatientdepartmentwasusedforselectionofantenatal
mothers with Gestational Diabetes Mellitus, to get consent and to check the weight.
The hospital conference hall which was at first floor was used to give instructions,
demonstration and practice of Yoga therapy .The laboratory which was near to the
outpatient department was used to carry out the planned investigations. The
researcherobtainedformalwrittenPermissionfromDirectorateofMedicalandrural
healthServices,Chennai,JointDirectorofhealthservicesKancheepuramand Chief
Senior Civil surgeon Medical Officer from Government General Hospital,
Tambaram to implement the intervention and to carry out the investigations and for
the follow upcare.
 60

POPULATION

PopulationforthisstudyconsistedofantenatalmotherswithGestational
diabetes Mellitus who were attending Antenatal Out Patient Department at
Government General Hospital, Tambaramtaluk.

TargetPopulation

The target population for this study was the entire Antenatal mothers
with the Gestational Diabetes Mellitus.

AccessiblePopulation

The Accessible population for this study was Antenatal Mothers with
GestationalDiabetesMellituswhowereattendingAntenatalOutPatientDepartment at
Government General Hospital, Tambaramtaluk.

SAMPLE

In this study the samples were antenatal Mother with Gestational

Diabetes Mellitus and those who fulfilled the inclusion criteria and who were
attending antenatal outpatient department at Government General Hospital,
Tambaram taluk.

CRITERIA FOR SAMPLESELECTION

InclusionCriteria

1. Mothers with present history of Gestational Diabetes Mellitus at 24 to 28

weeks of gestation, diagnosed byobstetrician

2. Mothers who were willing toparticipate.

3. Mothers who knows Tamil orEnglish.

4. Mothers whose level of practice in yoga was morethan 80%

ExclusionCriteria

1. Mothers with polyhydramnios, Multiple pregnancy and Pregnancy induced

hypertension
 61

2. Mothers with chronic conditions like Kidney diseases, Heart diseases,

Diabetes mellitus with treatment, Asthma, Tuberculosis, Epilepsy, Cancer,
Vasculardisease,Pulmonarydisease,Hypertension,poorlycontrolledthyroid
diseases.

3. Mothers with Obstetrical complications like persistent bleeding after 12

weeksofgestation,placentaprevia,severeanemiapresentbefore24weeksof
gestation and during the course of the study and mothers with the history
of
Miscarriagesandanyotherdiseasethatinterfereswiththeparticipationinthe
study.

4. Mothers who have been practicingyoga and exercise

5. Mothers who belongs to the category of Underweight, over weight and

Obesity

6. Mothers with visionabnormalities.

7. Mothers with vaginal, bladder and skininfections.

8. Mothers with orthopedic complications and who were unable to practice

yoga.

9. Mothers who developed excessive fatigue duringyoga.

3.8 SAMPLING TECHNIQUE

Non probability purposive sampling technique was used to select

220 samplesandmatchingofthesampleswerebasedonthelevelofClinicalparameters
of Gestational Diabetes Mellitus and which was described as follows normal
tolerance, mild, moderate and severe.It was divided based on the Fasting and
postprandial blood glucose level, Urine sugar level. For Weight BMI between18.5-
22.9 were only selected. In each subdivision 27-28 samples in study group and in
control group had been allotted. Quasi experimental study –pre and posttest design
was adapted. Antenatal mother with Gestational Diabetes Mellitus were selected on
the antenatal day which was only on Monday, Wednesday and Friday from
Government general hospital, Tambaram taluk for both the study group and control
group.
 62

3.9 SAMPLE SIZE AND SAMPLE SIZE CALCULATION

Thesamplesizeofthisstudywas220antenatalmotherswithGestational
Diabetes Mellitus who were attending the antenatal outpatient department at
Governmentgeneralhospital,Tambaramtaluk.Thestudygroupconsistedof110and
control group consisted of 110.The sample size calculation for the main study was
basedonthepilotstudyvaluesoffastingandpostprandialbloodglucosetest.Onthe
basisofpilotstudyresults,thefastingbloodglucosewas70mm/Hgandpostprandial
blood glucose was 90mm/Hg with standard deviation 32. After yoga therapy it was
expected a difference of 15 mm/Hg in fasting blood glucose and postprandial blood
glucose at 5% level of significance with 90% power. For achieving this difference
therequiredsamplesizewas96antenatalmotherswithGestationalDiabetesMellitus in
each group.15% of dropout was expected during the study. So the estimated
sample size was 110 in each group. Among 220 participants, they were sub divided
in to 27-28 samples in each group in study group and in control group based on the
level of Gestational Diabetes Mellitus as normal tolerance, mild, moderate and
severe.Todetectthesamplesize,thefollowingpoweranalysisformulawasused by
theinvestigator.

Anticipated common SD = 
Level of Significance = 100 (1-) %
Power of the Test = 100 (1-) %
Medically Meaningful Difference = d

n = 2 2 (Z+ Z)2
d2
 =

 = 1.96
 = 1.28
d = 15
n = 2 X 322 (1.96 + 1.28) 2 = 96 per group
152
 63

DEVELOPMENTANDDESCRIPTIONOFTHETOOLANDSCORING
INTERPRETATIONS

Extensive review of literature, discussion and views of experts

enhanced the development of the tool. The tool consists of three sections.

SECTION A: Consisted of Questions related to Demographic variables,

Obstetrical variables of antenatal mother with Gestational Diabetes
Mellitus andthe tool for Maternal, fetal and neonatal outcome
variable. Obstetrical variables which
werefurthersubdividedintoPastobstetricalhistoryandPresentobstetric
alhistory.

Part.I : Demographic Variableproforma

Consisted of Age ,Religion, Type of family, Educational status, Work

pattern, Income and Type of Marriage.

Part II: Obstetrical Variable proforma: it consistsof

Past obstetricalhistory

ThevariableswerediagnosisofGestationaldiabetesMellitusatprevious
pregnancy in gestational weeks, treatment of gestational diabetes at previous
pregnancy, previous history of type of delivery, weight of the previous child, effect
of diabetes in previous pregnancy, previous history of children with congenital
abnormalities and Family history ofdiabetes.

Present Obstetricalhistory

The variables were height, gravida, parity, abortions, still birth, death,
number of children and medication taken during pregnancy

PartIII:Maternal,fetalandNeonataloutcomevariableproforma

Maternal outcome: Weeks of gestation at delivery, Mode of delivery,

Complications duringlabour

Fetal outcome: Congenital malformation, Fetal macrosomia, Intrauterine growth

restriction, Intrauterine fetal death, Combined complications and No
Complications.
 64

3.10.1.3.3. Neonatal outcome: APGAR score at 1 st minute, 5th minute and Birth
weight of the baby and Neonatal complications.

3.10.2 SECTION B: It was a tool for surveillance of clinical parameters of

Gestational Diabetes Mellitus Which includes Blood glucose level (Fasting and
postprandial)whichwasestimatedbyGOD-PODmethod.Urinesugarlevel(Fasting
andpostprandial)wasmeasuredbydipstickmethodbytheinvestigator.Fastingurine
sugar level was assessed by collecting the second fasting urine specimen whereas
postprandial urine sugar level was assessed by a routine method Weight was
measuredbyISOcertifiedstandardweighingscalebytheinvestigator.Bodyweight was
measured (to the nearest 0.5 kg) with the subject standing motionless on the
weighing scale, feet about 15cm apart and weight equally distributed on each leg.
Subjectswereinstructedtowearminimumoutwear(asculturallyappropriate)andno
footwear while their weight being measured. The weighing machine was calibrated
by the bio-medical department experts.Totally the tool for surveillance of clinical
parametersofGestationalDiabetesMellitusconsistsof5items.

3.10.2.1 Scoring Procedures

The total score for the tool for surveillance of clinical parameters were
20(100%) and the total items were 5. It was assessed at the 24th week before Yoga
for study group and Control group, after Yoga with the hospital routine treatment at
28th week,32 week and 36th week in study group and with the hospital routine
treatment alone for Control group. The interpretations of the ranges were as follows

24th week 28th week 32ndweek 36thweek

S.No Clinical parameters
(Pre) (Post1) (Post2) (Post3)
1. Blood glucose level (mg /dl)
Fasting
2. Postprandial
Urine sugar level
3. Fasting
4. Postprandial
5. Weight gain
 65

3.10.2.1SCORINGINTERPRETATIONSFORTHECLINICAL
PARAMETERS
Sl.No. Ranges of Clinical parameters Classification Scoring

1) BLOOD GLUCOSE LEVEL

Fasting
a) 60mg/dl to less than95mg/dl Normal tolerance 1
b) 95 mg/dl to 120mg/dl Mild level 2
c) 121 mg/dl to 140mg/dl Moderate level 3
d) More than 140mg/dl Severe level 4
2 hour post prandial test
a) 90 mg/dl to less than 120mg/dl Normal tolerance 1
b) 120mg/dl tolessthan155mg/dl Mild level 2
c) 155mg/dlto200mg/dl Moderate level 3
d) More than 200mg/dl Severe level 4
2) URINE SUGAR LEVEL
Fasting
a)Blue(nil),Lightgreen(Trace,5mmol/L) Normal tolerance 1
b)Green(+1=15mmol/L) Mild level 2
c)Green (+2=30mmol/L) Moderate level 3
d)Orange(+3=60mmol/L) and Brickred Severe level 4
(+4=110 mmol/L)
URINE SUGAR LEVEL
Post prandial
a)Blue(nil),Lightgreen(Trace,5mmol/L) Normal tolerance 1
b)Green(+1=15mmol/L) Mild level 2
c) Green(+2=30mmol/L) Moderate level 3
d) Orange (+3=60mmol/L)and Severe level 4
Brickred(+4=110mmol/L)
3) WEIGHT ASSESSMENT
Second trimester
a)Not Less than1.5 Kg/Month Normalweightgain 1
b) More or less than 1.5 Kg/Month Abnormal weight 2
gain
Third trimester
a) Not Less than 0.5 Kg /Week Normalweightgain 1
b)More or less than 0.5 Kg/Week Abnormal weight 2
gain
Totalscore : 20= 100%
Normallevel :1-5 = 1 to25%
Mild level :6-10 = 26 to50%
Moderate level : 11- 15 = 51 to 75%
Severelevel : More than 15 = More than75%
 66

Reliability: The reliability for the tool for surveillance of clinical parameters of
Gestational Diabetes Mellitus was tested by Cronbach-Alpa, Rater-Inter-rater
method. The reliability was r = 0.78. It shows statistically significant and thus
reliable.

3.10.3SECTIONC:Toassessthelevelofsatisfactiononyogaamongmotherswith
GestationalDiabetesMellitus5pointratingscalewhichwasused.Totallyitconsists
of15itemsanditrangesfrom1-5(Verysatisfied-5,Satisfied-4,Neithersatisfiednor
dissatisfied-3, Dissatisfied-2, Very dissatisfied-1) and it was developed by the
investigator.

3.10.3.1 Scoring Procedures

Thetotalscoretoassessthelevelofsatisfactionon yogaamongmothers
withGestationaldiabetesMellituswas75.Itwasassessedafteryogaat28thweek,32
weekand36thweek instudygroup.Theinterpretationsoftherangeswereasfollows,
Total score=75 = 100%
Very satisfied = 61 to 75 = 81 to 100%
Satisfied=46 to 60 = 61 to 80%
Neither satisfied nor dissatisfied=31 to 45 =41 to 60%
Dissatisfied = 16 to 30 = 21 to 40%
Very dissatisfied = 1 to 15 = 1 to 20%
Reliability: The reliability for the level of satisfaction tool was tested by test-retest
method. The reliability was r = 0.86. It shows statistically significant and thus
reliable

DESCRIPTION OF THEINTERVENTION
The intervention package for study group consists of Yoga which
includes Yogic sukshma vyayama(20 -25 mts), Nadishodana pranayama(5-10 mts)
and Dhyanam(5 mts) with hospital routine treatment which includes Counseling on
diet,exercises,andregularmonitoringofbloodglucoselevel,Insulin therapybased
onthebloodglucoselevelandregulardoseofIron,folicacidandCalciumtablets
from 24th week to till delivery. They were instructed to follow up the visitsregularly
in the antenatal outpatient department. The intensive training on yoga was given to
the mothers with GDM for 6 days continuously for 30-40 minutes a day and the
doubts were clarified by the Investigator.
 67

The plan of Intensive yoga session for 6 days was as follows

DAY/SESSION PLAN OF INTERVENTION DURATION
Introduction to self, teaching about Gestational
Diabetes Mellitus, clinical features and its
management, orientation to yoga which includes
Day 1 2 hrs
Sukshma vyayamas, Pranayama-Nadishodana
pranayama and Meditation- Dhyanam and its
Benefits
Orientation to yoga - Sukshma vyayamas and
demonstration of steps of Sukshma vyayamas by
Day 2 2 hrs
the investigator and practice of Sukshma
vyayamas by the antenatal mothers with GDM
Practice of Sukshma vyayamas by the antenatal
mothers with GDM and demonstration of steps of
Day 3 2 hrs
Pranayama- Nadishodana pranayama(breathing
exercise) by the investigator
Practice of Sukshma vyayamas and Pranayama-
Nadishodana pranayama(breathing exercise) by
Day 4 the antenatal mothers with GDM and 2 hrs
demonstrationofstepsofMeditation-Dhyanamby
the investigator
Practice of Sukshma vyayamas,Pranayama-
Nadishodana pranayama(breathing exercise) and
Day 5 Meditation-Dhyanam by the antenatal mothers 2 hrs
with GDM and clarification of doubts by the
Investigator
Practice of Sukshma vyayamas, Pranayama-
Nadishodana pranayama (breathing exercise) and
Meditation-Dhyanam by the antenatal mothers
with GDM and clarification of doubts by the
Day 6 2 hrs
investigator. Assessment of level of practice by
the checklist, distribution of booklet and yoga
practicecalendarandinformationregardinggroup
yoga practice was done by the investigator
 68

After the intensive training of Yoga for 6 days the antenatal mother with
GDM practiced yoga daily at home for 30-40 minutes a day and group session
weekly once was conducted as a reassessment and reinforcement from 24th week to
tilldelivery.Investigatorbyparticipatoryobservationassessedthecorrectpracticeof
the yoga with the check list in every group session to assess the level of practice.
Daily yoga practice calendar was used to verify the regular practice of yoga by the
antenatal mother with GDM.

Intervention Fidelity

Intervention fidelity, defined as the adherent and competent delivery of

aninterventionbytheinterventionistassetforth intheresearchplan,is fundamental
totheinferenceofvalidityinnursinginterventionresearch.Thenursingliteratureon
intervention fidelity has included adherence, defined it as the degree to which the
prescribed elements of an intervention have been delivered and prescribed elements
avoided.Theattentionontheinterventionist’sbehaviordistinguishesthemeaningof
adherence as it is used in this report from the meaning of adherence associated with
whethertheclientcarriedouttheprescribedactivitiesornot.Competenceisdefined as the
extent to which the interventionist has displayed behaviors that typically engage
participants in the intervention and affect outcomes in the desired direction.
Becauseaninterventionist’sabilitytoengageparticipantscanaffectwhetheroffered
interventions are used and have adequate opportunities to produce change, both
adherence and competence assessments are necessary for an inference of
validity.[159]

Toassessinterventionfidelityin thisstudytheinvestigatorusedchecklist
which consisted of 5 components such as Study design, Treatment and its delivery,
Treatment / Intervention receipt, Treatment enactment and Provider training. This
check list was validated by many experts in the field of research and it was used by
theinvestigator.Thistoolwasusedtoassesstheadherentandcompetentdeliveryof yoga
which includes sukshma vyayama(20 -25 mts), Nadishodana pranayama(5-10 mts)
and Dhyanam(5 mts) with hospital routine treatment (Intervention) by the
interventionist to the antenatal mothers with GDM. The total score was30 out of
 69

which this study intervention fidelity score was 27 (90%). Hence the intervention
was delivered adherently and effectively in this study to all the antenatal mothers
with GDM in study group.

TRANSLATION AND BACK TRANSLATION OF THETOOL

TheentireabovesaidtoolsweretranslatedintoTamilbyexpertsandthis
Tamilinstrumentwasbacktranslated in toEnglishbyexpertstoimprovevalidityof the
tool and again the tool was given to experts for Content validity. Based on their
valid suggestions, the tool was prepared andadministered.

CONTENT VALIDITY OF THETOOL

The content of the tool was validated by panel of experts from the field
of Nursing (Obstetrics and Gynecology), Obstetricians, Yoga practioners, Bio-
Statistician and Research experts by the Content Validity Index which was prepared
by the Investigator. Minor suggestions and modifications given by the experts were
incorporated in the final preparation of the tool.

RELIABILITY OF THETOOL

Reliability of the tool was assessed by using cronbach-Alpha- Rater-

Inter-rater method, Test-retest method. Reliability correlation coefficient value is
0.78forclinicalparameterswhichwasassessedbycronbach-Alphamethod,0.86for level
of satisfaction on yoga and it was assessed by test-retest. This correlation
coefficientvaluewasveryhigh enoughtousethistoolforthestudy.

ETHICALCONSIDERATIONS

The investigator considered and followed the ethical priniciples

preceding the investigation. The investigator adhered to the following actions in
orderto protecttheethicalrightsoftheAntenatalmotherswithGestationalDiabetes
Mellitus.
 70

Human rights

1. Formal approval was obtained from the Institutional review board and
InstitutionalethicalcommitteeofSRMUniversity,Kattankulathur,Chennai,
Tamilnadu,India.

2. To executethestudytheresearcherobtainedofficialwrittenpermissionfrom
Directorate of Medical and rural health Services, Chennai, Joint Director of
health services Kancheepuram and Chief Senior Civil surgeon Medical
Officer from Government General Hospital, Tambaram.

3. Content validity was received from the various experts from the field of
Nursing (Obstetrics and Gynecology), Obstetricians, Yoga practioners, Bio-
Statistician and Researchexperts

Beneficence and Non-malefficience

4. TheinvestigatorwascertifiedtoexecutetheyogaforGestationalDiabetes

Mellitus.

5. PotentialbenefitsandriskwasexplainedtotheAntenatalmotherswith

Gestational DiabetesMellitus.

Dignity

6. Informedconsentwasobtainedfromthesamplesandtheircaretakersrelated to
the study purpose, type of data, nature of commitments, participation and
procedure.

7. Pilot study was executed to check the feasibility and time requirement of
the study.

8. Mothers with Gestational Diabetes Mellitus have the “rights to with draw
the/withholdtheinformation”wasenforcedbeforedatacollection.

9. Investigator’s contact information was disseminated to all antenatal

mothers with GDM those who have participated in thestudy.
 71

Confidentiality

10. Confidentiality and anonymity pledge wasensured.

Justice

11. The control group received hospital routine treatment which includes
Counselingondiet,exercises,andregularmonitoringofbloodglucoselevel,
Insulin therapy based on the blood glucose level and regular dose of Iron,
folic acid and Calcium tablets from 24 th week to till delivery

12. Levelofsatisfactionforyogawasassessedinthestudygroup.

PILOTSTUDY

The pilot study was conducted in the Government general hospital,

Tambaram.Basedontheinclusionandexclusioncriteria,Nonprobabilitypurposive
sampling technique 22 mothers with Gestational Diabetes Mellitus (11 in Study
group and 11 in Control group) were selected. The preliminary assessment, clinical
parameters were assessed for both the groups. Study group received the routine
hospital treatment which includes Counseling on diet, exercises, and regular
monitoring of blood glucose level, Insulin therapy based on the blood glucose level
andregulardoseofIron,folicacidandCalciumtabletswithYogapracticefor6days
asintensivephaseandthereaftermotherswereaskedtoperformyogadailyathome till
6weeks.Reinforcement sessions were given weekly once in the hospital. During the
intensive phase, the yoga was taught daily on one to one basis and at the end of
every week group sessions were conducted, Daily practice sheet to assess the
compliance and booklet for their self-reference was provided after the intensive
phasetothestudygroup.Thecontrolgroupreceivedonlytheroutinetreatment from the
hospital. The Clinical parameters were assessed after 6 weeks for Study Group and
for Control Group. The findings revealed that, there was a significant reduction in
the posttest level of clinical parameters such as fasting and postprandial blood
glucose and Urine sugar level (p<0.001) and the normal weight gain (p<0.001).The
report of the pilot study revealed that the setting was feasible, to conduct the main
studyandtheyogawaseffectiveforthemotherswithGestationalDiabetesMellitus.
 72

The following suggestions were drawn from the pilot study

1. Matching of the samples were done based on the level of Gestational

Diabetes Mellitus in study and in controlgroup.

2. Sample size was increased from 160 to 220 including study group and
Controlgroup.

3. Formulatedatooltoassessthematernal,fetalandneonataloutcomeandlevel
of satisfaction onyoga.

METHOD OF DATACOLLECTION

The total data collection process was one year.The researcher obtained
formal written permission from Directorate of Medical and rural health Services,
Chennai, Joint Director of health services Kancheepuram and Chief Senior Civil
surgeon Medical Officer from Government General Hospital, Tambaram Oral,
written consent from the samples and their care takers were received.

Thedatacollectionprocesscompletedforcontrolgrouppriortothestudy
groupanditwasasfollows.Theinvestigatorhadcommunicatedwithalltheantenatal
mothers with Gestational Diabetes Mellitus those who were attending the antenatal
outpatient department at Government general hospital, Tambaram and explained in
detail about the research study, to find out the interested antenatal mothers with
Gestational Diabetes Mellitus for thestudy.

The data collection procedure was started in the month of June 2010 and
it was completed in the month of June 2011.Investigator had attended the antenatal
outpatient department 3days per week that was Monday, Wednesday and Friday, to
select the mothers with Gestational Diabetes Mellitus on the basis of inclusion and
exclusioncriteria.
 73

Samples were selected by non-probability purposive sampling technique

and matching of the samples were based on the level of Clinical parameters
Gestational Diabetes Mellitus as follows normal tolerance, mild, moderate and
severewhichwasdividedbasedontheFastingandpostprandialbloodglucoselevel,
UrinesugarlevelandforWeightBMIbetween18.5-22.9wereonlyselected.Ineach
subdivision27-28samplesinstudygroupandincontrolgrouphadbeenallotted.The
investigator received a written consent from all the selected antenatal mothers with
Gestational Diabetes Mellitus and from their care takers of both study group and
controlgroup.Thedatacollectionprocedureforcontrolgroupwascompletedbefore
thestudygroupdatacollectionprocedureto avoidcontamination.

Pretest : Study and Control group

On the first day of contact, the investigator collected the information

about socio demographic variables and Obstetrical variables from all the selected
antenatal mothers with Gestational diabetes Mellitus of Study and control group by
structured interview schedule. The investigator had spent 10 to 15 minutes per
sampletocollectthatinformation.ThentheinvestigatorhavedonethePretestat24th week
to assess the tool for surveillance of clinical parameters (Fastingand
postprandialbloodglucose,Urinesugarandweight)ofGestationalDiabetesMellitus for
Study and controlgroup.

Intervention for Control Group

After completion of pretest, the mothers with Gestational Diabetes

Mellitus in Control group were received the routine hospital treatment which
includes Counseling on diet, exercises, and regular monitoring of blood glucose
level,InsulintherapybasedonthebloodglucoselevelandregulardoseofIron,
folicacidandCalciumtabletsfrom24thweektotilldelivery.Theywereinstructedto
follow up the visits regularly in the antenatal outpatient department
 74

Post Test : Control group

Posttest was done by using the same tool for surveillance of clinical
parameters (fasting and postprandial blood glucose, urine sugar and weight) of
GestationalDiabetesMellitusat28th,32and36thweek(4weeksonce)andMaternal, fetal
th
and neonatal outcome were assessed after 36 week. Maternal, fetal and
neonataloutcomewereassessedfromtheirmedicalrecords.Allthesedatacollection
procedure for control group was completed before the study group data collection
procedure.

Intervention for Study Group

In study group after completion of pretest they received Yoga which

includes Yogic sukshma vyayama(20 -25 mts), Nadishodana pranayama(5-10 mts)
and Dhyanam(5 mts) with hospital routine treatment which includes Counseling on
diet, exercises, and regular monitoring of blood glucose level,Insulin therapybased
on the blood glucose level and regular dose of Iron, folic acid and Calcium tablets
from 24th week to till delivery. To perform yoga intensively the antenatal mothers
with Gestational Diabetes Mellitus were grouped about 22 in each session and were
briefed and demonstrated about the steps of Yoga.After that along with the
investigator instruction mothers were performed yoga in groups for 6 days
continuously.To support the practice, booklet contained general instruction of
Gestational Diabetes Mellitus and the steps of yoga were given at the end of the
session. After 6 days of intense practice of yoga by the study participants,
investigator assessed the correct practice of yoga with the checklist. Practice scores
were assessed and more than 80% of the scores were eligible to continue the
study.Thedoubtswereclarifiedbytheinvestigator.Aftertheintensivetraining,yoga was
done by the study participants daily at home for 30-40 minutes a day, from 24
weeks of gestation to till the end of the pregnancy. Group session weekly oncewas
conducted as a reassessment and reinforcement from 24th week to till
 75

delivery.Investigatorbyparticipatoryobservationassessedthecorrectpracticeofthe yoga
with the check list in every groupsession

Post Test : Study group

Posttestwasdoneto assessthetoolforsurveillanceofclinicalparameters
(fasting and postprandial blood glucose, urine sugar and weight) of Gestational
Diabetes Mellitus for study group at 28th, 32 and 36th week
(4 weeks once) and Maternal, fetal and neonatal outcome were assessed after 36th
week and level of satisfaction on yoga was assessed in study group at 28,32 & 36th
week.Maternal,fetalandneonataloutcomewereassessedfromtheirmedicalrecords

DROP OUTS AND ITSANALYSIS

After assessing the initial values of Clinical parameters,6 Mothers from

studygroupand2mothersfromcontrolgrouphadwithdrawnfromtheirstudy.Butit was
not affected the study because the investigator expected the 10% drop outs and
chosen appropriate number ofsamples.

DROP OUTANALYSIS

STUDYGROUP

SAMPLE.NO 21 35 51 62 91 95

AGE 32 25 22 31 19 27

REASON D B A C B E

CONTROLGROUP

SAMPLE.NO 45 62

AGE 20 23

REASON D B
 76

REASON FOR DROPOUT

A. No time to practice Yogatherapy

B. Shifting ofresidence

C. No belief in Yogatherapy

D. Complications developed due toGDM

E. Difficulties in practicingyoga

FREQUENCYANDPERCENTAGEDISTRIBUTIONOFDROPOUT
ANALYSIS FOR STUDY AND CONTROLGROUP

CODE REASON FOR DROP OUT STUDY GROUP CONTROL

GROUP
n(6) % n(2) %
A No time to practice Yoga 1 16.6 - -
therapy
B shifting of residence 2 33.3 1 50
C No belief in Yoga therapy 1 16.6 - -
D Complications developed due 1 16.6 1 50
to GDM
E Difficulty in Practicing yoga 1 16.6 - -

PLANS FOR DATAANALYSIS

The data was collected from 104 mothers with Gestational Diabetes
Mellitus in study group and 108 mothers with Gestational Diabetes Mellitus in
controlgroup.The informationcollectedfromthestudyparticipantswasscoredand
tabulated. The data was entered into the master coding sheet and saved in EXCEL.
Then the data was analyzed using Statistical Package for Social sciences (SPSS-
16).Thedatawasanalyzedbyusingdescriptiveandinferentialstatistics.
 77

Structured Data Analysis Process

S.No Type of Statistics Variables assessed

1 Descriptive Statistics Demographic, Obstetric, maternal, fetal and
Mean, percentage and neonatal outcome variables
Standard deviation
2 Inferential Statistics Assess and compare the clinical
1.Paired ‘t’ test and parameters(Fasting,Postprandial bloodglucose
Repeated measures and Urine sugar,Weight gain) of GDM within
ANOVA the study and control group
2.Unpaired ‘t’ test Assess and compare the clinical parameters
(Fasting,Postprandial bloodglucose and Urine
sugar,Weight gain) of GDM between the study
and control group.
3.Chi-square test, Association of clinical parameters
Multiple regression (Fasting,Postprandialbloodglucose and Urine
analysis sugar,Weight gain) of GDM with their
demographic, Obstetric, maternal, fetal and
neonatal outcome variables in the study and
control group

CHAPTER SUMMARY

Chapter-3 was devoted to the methodology which includes aspects like Research
approach, Research design, Variables in the study,Setting, Population, Sample and
Sample size and its calculation, Sampling technique, Criteria for sample selection,
Development and description of the tool and its scoring procedure, Description of
intervention,Interventionfidelity,Pilotstudy,Validityofthetool,Reliability,Ethical
consideration,Datacollectionprocedure,DropoutsanditsanalysisandPlanfordata
analysis.

Chapter-4:Presentstheanalysisandinterpretationsofdatawhichwascollected

duringthestudy.
 78
Population

Antenatal Mothers with Gestational Diabetes Mellitus

Setting

Government Hospital , Tambaram

Samples

AntenatalMotherswithGestationalDiabetesMellitus
who fulfils the Inclusioncriteria

Sampling Technique

Non-Probability purposive sampling technique

Sample size

220 Samples ( 110 in Study group & 110 in Control Group).

MatchingwasdonebasedonthelevelofGestationalDiabetesMellitus(Normal,Mild,
Moderate andSevere)

Study group ( n=104)

Control Group(n=108)
Yoga with hospital routine Routine hospital
treatment Measures
1. Yogicsukshmavyayama-20-25mts
2.Nadishodana pranayama-5-10 mts
3.Dhyanam-5mts
 79

AssessmentofthelevelofClinicalParametersofGest
ationalDiabetesMellitus(24,28,
32,36weeksofGestation),Maternal,FoetalandNeon
ataloutcomeinbothStudyand Control Group(After
delivery) and level of satisfaction on yoga in
Study group ( 28, 32,36 weeks ofGestation)

Plan for Data analysis (Descriptive and

inferential statistics)

FIG-
3.1SCHEMATICREPRESEN
TATIONOFRESEARCHMET
HO

79
80

80
 81

CONCLUSION
Patients' knowledge regarding the treatment and
complications of diabetes showed serious
deficiencies, more so among women, even though
most had been diabetic for years.
1)A significant predictor for lower knowledge scores
was female gender. In this study, the mean score of
the women was 2.84 points lower than that of men
(t = 2.44, P = 0.016).
2)This finding was similar to that reported by
Vishwanathan et al, who conducted a study on the
knowledge of diabetic subjects regarding foot
problems and care of feet.
(3) They demonstrated that a low knowledge score
was more common among women than in men. In a
study conducted in Chandigarh, it was again shown
that knowledge concerning the prevention of
diabetes complications was partial amongst
diabetics, with only 63.3% of the diabetics taking
care of their feet through regular washing.

81
 82
(4) The fact that 51 (50.5%) patients thought that
diabetes is curable, and that only 64 (63.4%) patients
correctly said that the treatment continues
throughout the life, may reflect a mentality of
patients that once the blood sugars are controlled,
they can stop taking their medicines. Only 47
(46.5%) correctly said that diabetes is preventable
and only 29 (28.7%) were aware of the causes of
diabetes.
This indicates a significant lack of the knowledge of
primary and primordial prevention of diabetes in the
population. This fact along with that 71 of the 101
(70.3%) patients said that they would either
definitely or probably have taken preventive
measure seriously had they known that diabetes was
preventable means that imparting knowledge
regarding prevention should be a major thrust in the
future.

82
 83

BIBLOGRAPHY
In this project report, I have made use of
books,magazines/journals and web sites which have
been referred.All the material detailed below
provides effective help and a guiding layout while
designing this project report.
WEBSITES:
Wikipedia
Microlabs ltd

MAGAZINES:
Pc magazines
Media kit
NEWSPAPERS:
The times of india, The Hindustan times,The
economic times

83
84

84