Annexure II

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.

Name of the candidate and address (in block letters)

ABHINAND R. S.

I YEAR M. Sc. NURSING

LAXMI MEMORIAL COLLEGE OF NURSING

BALMATTA

MANGALORE

2.

Name of the Institution

LAXMI MEMORIAL COLLEGE OF NURSING

BALMATTA

MANGALORE

3.

Course of Study and Subject

M. Sc. NURSING

MEDICAL SURGICAL NURSING

4.

Date of Admission to the course

12.06.2012

5.

Title of the Topic

EFFECTIVENESS OF YOGIC PRACTICES ON GLYCEMIC CONTROL AND BODY MASS INDEX AMONG TYPE-2 DIABETES MELLITUS PATIENTS IN A SELECTED HEALTH CENTRE AT MANGALORE

6.

Brief resume of the intended work

6.1Need for the study

Diabetes is a complex condition, with a multitude of metabolic imbalance, involving the regulation and utilization of insulin and glucose (sugar) in the body. Although currently, considered as an epidemic disease, it can be prevented and treated through diet, exercise and lifestyle changes. Type 1 and type 2 are the two classifications of diabetes mellitus. Type 2 diabetes mellitus is defined as a heterogeneous disorder involving both genetic and environmental factors and it was previously called non-insulin dependent diabetes mellitus or adult-onset diabetes.1

Non communicable diseases (NCDs) are chronic diseases that are of long duration and generally slow in progression. The four main types of non communicable diseases are cardiovascular diseases (like heart attacks and stroke), cancers, chronic respiratory diseases (such as chronic obstructed pulmonary disease and asthma) and diabetes2. Children, adults and the elderly are all vulnerable to the risk factors that contribute to non communicable diseases, whether from unhealthy diets, physical inactivity, exposure to tobacco smoke or the effects of the harmful use of alcohol. These diseases are driven by forces that include ageing, rapid unplanned urbanization, and the globalization of unhealthy lifestyles. Historically, many NCDs were associated with economic development and were so-called a "diseases of the rich and two-thirds of people affected by diabetes are now residing in developing nations. Increasing urbanisation in countries such as India and China has led to adoption of Western-style diets and sedentary patterns that have dramatically increased the number of people with type 2 diabetes. Such practices led to the occurrence of type 2 diabetes on a large scale when compared to other NCD’s.3

The prevalence of Type 2 diabetes worldwide has more than doubled since 1980, climbing from an estimated 153 million three decades ago to about 347 million in 2008. According to WHO report, today around 346 million people worldwide have diabetes. In 2004, an estimated 3.4 million people died from

consequences of high blood sugar.4 About one in every 10 men around the world and one in every 11 women suffers from this disorder. According to the Diabetes Atlas published by the International Diabetes Federation, the number of people with diabetes in India currently around 40.9 million and is expected to rise to 69.9 million by 2025 unless urgent preventive steps are taken.5 India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed the “Diabetes capital of the world”6. In Dakshina Karnataka district in the year 2010 was found to be 57% where as that of females was 43%. The prevalence of type 2 diabetes among the adult over weight male residents in Dakshina Karnataka District in the year 2010 was found to be 57% whereas that of females was 43%. The prevalence of type 2 diabetes among the adult overweight male residents in Dakshina Kannada district was found to be 62% where as that of overweight females were 53 percentage7. In Mangalore 2002 cases of diabetes mellitus were reported in 2004 that reduces to 1624 in 2005, increased to 1834 in 2006 and further decreased to 1554 in 2007. Around 3.2 million deaths every year are attributable to complications of diabetes: six deaths every minute. India tops the list of 10 countries in numbers of suffers8.

According to dietary recommendations increasing the fibre in diet is useful as fibre, a substance that occurs naturally in plants and vegetables, is indigestible and acts as a potent filler, and when the stomach is full there less chance to consume excessive calories that will impact blood sugar. Exercise and rest are equally important, and attending a yoga class will be beneficial. Stress, illness and sedentary lifestyles will raise the blood glucose levels whereas exercise and relaxation can lower them. Insulin or other oral anti diabetic agents are required if lifestyle changes such as diet and exercise do not control the blood glucose levels enough. Weight loss also helps to bring your blood glucose levels under control, improve your triglyceride levels and lower your blood pressure.9 .Yoga: According to Indian religions, yoga (from the Sanskrit word meaning “yoking” or “joining”) is “the means or techniques for transforming consciousness and attaining liberation (moksha) from karma and rebirth (samsara). Yoga is popularly understood to be a program of physical exercises

(asana) and breathing exercises (pranayama).Yoga began in India as early as 3000 B.C. according to archaeological evidence. It emerged in the later hymns of the ancient Hindu texts. Yoga was systemized by Patanjali in the Yoga Sutras. Patanjali defined the purpose of yoga as knowledge of the true “Self ” (God) and outlined eight steps for direct experience of “Self.” 10. Suryabhedana pranayama, Chandrabhedana pranayama, Nadishodhana pranayama, Matsyendrasana, Vakrasansas etc has been widely in application for glycaemic control in diabetes patients as it maintains balance between ida & pingala nadis, relaxes the mind, cleanses the nadis & brings about stability in breathing pattern11.

The body mass index (BMI) is a measure of body fat based on a formula that calculates the ratio of an individual’s height and weight. BMI is an indicator of appropriate weight for a particular height and is a more reliable indicator of body fat than just weight alone. If the BMI is above the normal range then there is greater risk for developing type 2 diabetes. Hasta uttanasana, Utkatasana, Veerabhadrasana, Vakrasana & Trikonasanas are employed for getting control over obesity as these asanas helps to strengthen the muscles, reduces fat deposition from waist region, stimulates the visceral organs like stomach, liver, intestines.12

A randomized trial to study the potential of yoga therapy as an aid to the management of non-insulin-dependent diabetes mellitus (NIDDM) was carried out in Royal Free Hospital London, where 21 patients with NIDDM, out of which (13) were on medication and (8) on diet control alone were selected and patients were randomized to control (11) and yoga (10) group. Both continued their normal medication and diet. The control group had no additional intervention. The yoga group was offered yoga classes with a standard set of postural, breathing and relaxation exercises; most patients attended one or two classes per week and both FBG & HbAlc improved significantly (P<0.05) in the yoga group, compared to the controls, three patients in the yoga group were able to reduce their medication. Most patients in the yoga group wanted to continue attending yoga classes, and reported feeling better, less anxious and more in control of themselves. No adverse effects were observed which concluded that offering yoga

classes to NIDDM patients at a diabetic clinic attracted significant numbers of patients and led to improved glucose homeostasis.13

During the clinical experience, the investigator observed that clients were depending too much on the conventional methods of treatment which had many hazardous side effects and this became an inspiration to carry out the study so as to employ the indigenous system of yoga in determining the effects it brings about in glycaemic control and body mass index.

6.2Review of literature

A Siddha Samadhi Yoga (SSY) camp which is believed to invoke the intellectual, emotional, mental and physical potential in view of the beneficial effects of Yoga, Meditation and changed food habits was conducted in Mahaboob Nagar and Tirupathi out of which 30 normal and 30 diabetic male subjects free from additional complications belonging to 25 to 45 years of age were selected from two camps. Diet Survey was conducted on the basis of food intake record provided by the subjects, food habits of normal and diabetic subjects were also studied before and after the camp. The BMI of all subjects were calculated and compared with standard classification of James et al. (1998) and blood samples were analysed for post prandial blood glucose; serum cholesterol; serum iron and haemoglobin levels. There was a significant difference in pre and post prandial blood glucose level of Normal subjects (t = 4.9811 > 2.05) and Diabetics (t = 24.4962 > 2.05) and the percent reduction in BMI is 4.2 and 4.1 in normal and diabetic subjects respectively. Serum cholesterol levels among diabetics reduced by 4.1% and by 2.99% in normal subjects and Serum Iron and haemoglobin levels improved in normal subjects by 8.4% and 14.95% respectively in normal subjects while by 5% and 6.9% respectively in diabetics.14

An interventional study was conducted in the Department of physiology of S.N. Medical College, Bagalkot to ascertain effects of a short-term practice of pranayama and meditation in improving the cardiovascular functions in healthy individuals with respect to age, gender, and body mass index (BMI). Fifty healthy

subjects of 20–60 years age group, fulfilling the inclusion and exclusion criteria underwent two hours daily yoga program (Prayer – 10 mins, Pranayama – 45 mins, Short break – 5 mins, Lecture or film on fundamentals in nutrition, stress management, meditation and yogic attitude in daily life – 30 mins, Meditation – 20 mins, Prayer – 10 mins) for 15 days taught by a certified yoga teacher. Pre and post yoga cardiovascular functions were assessed by recording pulse rate, systolic blood pressure, diastolic blood pressure, and mean blood pressure. On analysis of the physical characteristics of the 50 subjects, the mean age (years) was 38.60 ± 8.89, the mean height (cm) was 159.38 ± 9.97, the mean weight (kg) was 64.21 ± 9.24 and the mean BMI (kg/m2) was 25.31 ± 3.29. Both the genders were age matched with significant variation in height (P < 0.001), weight (P=0.003), and BMI (P=0.025).The mean resting pulse rate (beats/min), mean resting systolic, diastolic and mean arterial blood pressure (mm Hg) were reduced significantly after 15 days of yoga practice.15

A study was conducted in Department of Medicine, S.P. Medical College, Bikaner to ascertain the effect of Pranayama and certain yogic asanas on parameters of obesity viz. Weight reduction (BMI and waist hip ratio), Blood pressure and lipid profile. In this study 150 patients were included after screening by inclusion and exclusion criteria for obesity, hypertension, dyslipidemia and these patients were randomly segregated in two groups each group has 75 patients. Group I was the study group for evaluation of the effect of yoga and certain asanas in addition to the dietary and other lifestyle modification and Group II was given instruction on dietary and lifestyle modification but was asked not to do yoga and asanas. In this study pre treatment BMI was 29.03+ 4.83 in the study group and 27.92+2.21 in the control group, when compared with BMI after 3 months it was 26.63+4.59 in the study group and in the control group it was 27.94+2.24. This study showed improvement in BMI in the study group which was at pre treatment 29.03+4.83 and after 3 month of yoga therapy was 26.63+4.59 it was statistically significant(P=0.001). Systolic blood pressure decreased from 132.79+15.40 mm Hg to 126.88+ 13.57 mm Hg. Diastolic blood pressure reduced from 85.08+ 8.92 mm Hg to 81.14+ 5.70 mm Hg. (P=0.001,

P=0.001) respectively. In this study lipid profile, i.e., total cholesterol decreased from 203.73+ 60.38 mm/dl to 181.92+ 43.34 mm/dl (P=0.001) triglyceride decreased from 168.26+ 92.33 mm/dl to 136.50 +73mm/dl (P=0.003).16

A study was conducted at the MRPL ladies club auditorium in the MRPL Township, Karnataka on the effect of yoga therapy on Body Mass Index and oxidative Status to assess the effect of selected yogic practices which included Swastikasana, Vajrasana, Suptavajrasana, Tadasana, Trikonasana, Bhujangasana, Dhanurasana, Viparitakarani and Uttanapadasana and the pranayama techniques used were Ujjayi, Anuloma viloma and Bhastrika in obese male and female subjects belong to the age group of 48 ± 13 years showed that the obese individuals reduced their Body Weight, Lipid Peroxidation, Blood Sugar and Total Antioxidant Level. The significant reduction in Body Weight (p=0.000), BMI (p=0.000) Fasting Blood Sugar(p=0.03) and post prandial blood sugar (p=0.000).17

Effect of yoga on heart rate and blood pressure and weight (BMI) in 50 healthy volunteers above the age of 40 years (20 females and 30 males) performing yoga regularly was conducted in Chalmeda Anand Rao institute of medical sciences, Karimnagar. The cardiovascular status of the subjects was assessed clinically in terms of resting heart rate and blood pressure before the start of yoga practice and again after 6 months of yoga practice. The subject was asked to relax physically and mentally for 30 minutes and blood pressure was recorded with the sphygmomanometer in supine position in the right upper limb by auscultatory method. Similarly, three readings were taken at an interval of 15 minutes each and average of the three values calculated. ECG was recorded by an ECG. Heart rate was calculated from the tracings. Each ECG was reported by trained physician. They carried out yoga for 6 months for 1 hour daily between 6 am and 7 am. The results were compared and analysed with respect to age, sex and body mass index and significant reduction in the heart rate occurred in the subjects practicing yoga (P < 0.001). The systolic blood pressure was lowered to a highly significant level (P < 0.001). The diastolic blood pressure was reduced significantly (P < 0.001). The reduction in weight was compared between two

groups age < 50 years and age > 50 years, it was found that after 6 months of yoga practice, in the age group of < 50 years, the weight reduced from 64.6 ± 11.6 to 62.1 ± 10.7; where as in the age group of > 50 years the weight reduction was from 63.2 ± 9.3 to 62.4 ± 8.8. The difference in response these two groups is significant, the response being more in the age group of < 50 years.18

6.3Statement of the problem

Effectiveness of yogic practices on glycemic control and body mass index among type-2 diabetes mellitus patients in a selected health centre at Mangalore.

6.4 Objectives of the study

1. To determine the pre intervention glycaemic level & BMI of both experimental and control group with type 2 diabetes.

2. To determine the effectiveness of yogic practices on glycaemic level in the experimental group with type 2 diabetes.

3. To determine the effectiveness of yogic practices on BMI in experimental group with type 2 diabetes.

4. To determine the association of glycaemic level and BMI with selected demographic variables.

6.5Operational definitions

1. Effectiveness: refers to degree to which objectives are achieved and the extent to which targeted problems are resolved.

In this study effectiveness refer to determining the extent to which yogic practices has achieved the desired effect by a significant reduction in the glycaemic level, and body mass index in type 2 diabetic clients.

2. Glycaemic control: is defined as the control over the presence of glucose in blood as measured by glucometer.

3. Body mass index: is defined as the weight in kilograms divided by the height in metres squared.

4. Yogic Practices: refers to those doctrines that aim at training the consciousness for a state of perfect spiritual insight and tranquillity.

In this study Vakrasana is used by the subjects for getting control over diabetes mellitus & obesity.

5. Type 2 Diabetes: is a metabolic syndrome in which carbohydrate use is reduced and that of lipid and protein enhanced; caused by an absolute or relative deficiency of insulin production secretion or both and is characterised by chronic hyperglycaemia, glycosuria, water & electrolyte loss, ketoacidosis and coma.

6.6Assumptions

The study assumes that;

· Different yogasanas can be used as a mode of intervention in controlling diabetes and obesity19, 20

· Diabetes mellitus is a potential health problem among middle age and old age persons21.

· Yoga therapy can be used in adjunct to conventional therapy in the treatment of diabetes mellitus and obesity22.

6.7Delimitations

The study is delimited to:

1. Blood sugar will be assessed by FBS and PPBS glucometer readings only.

2. The study is delimited to diabetic patients who are in the age group of 30-70 years of age.

6.8Hypotheses

The hypotheses will be tested at 0.05 level of significance.

H1:There is a significant difference in glycaemic level before and after exercising yogic practices among diabetic patients in the experimental group.

H2:There is a significant difference in BMI values before and after exercising yogic practices among diabetic patients in the experimental group.

H3:There is a significant difference in post intervention glycaemic level among diabetic patients in the experimental and control group.

H4:There is a significant difference in post intervention BMI values among diabetic patients in the experimental and control group.

H5:There will be an association between the post test values with selected demographic variables in the experimental group.

7.

Material and Methods

7.1 Source of data

The data will be collected from diabetic clients in a selected health centre in Mangalore.

7.1.1 Research design

Time series research design.

E = O1 x O2 O3 O4

C = O1 – O2 O3 O4

O1 =the pre intervention glycaemic level and BMI values of clients on the 1st day.

X=the intervention or yogic practices taught to the client on the second day.

O2 =the post intervention glycaemic level and BMI values of clients on the 30th day.

O3 =the post intervention glycaemic level and BMI values on the 31st day.

O4 =the post intervention glycaemic level and BMI values of clients on the 32nd day.

7.1.2 Setting

The study will be conducted in a selected health centre in Mangalore.

7.1.3 Population

In this study, population consist of diabetic clients aged between 30-70 years.

7.2 Method of data collection

7.2.1 Sampling procedure

In this study, non probability purposive sampling will be used to select the samples and to assign them randomly to experimental group and control group.

7.2.2 Sample size

In this study the sample size will be 40 diabetic clients from selected health centre in Mangalore. Out of 40 diabetic clients, 20 each will be to the experimental group and the control group.

7.2.3 Inclusion criteria

1. The clients who are diagnosed by the physician of having type 2 diabetes mellitus.

2. Diabetes clients who are at the age group between 30-70 years, both men and women.

3. Diabetic clients who are willing to participate in the study.

7.2.4 Exclusion criteria

Diabetic patients who:

1. Have any comorbidities like respiratory complications, cardiac complications, peripheral vascular diseases, stroke.

2. Are confused, disoriented or not willing to take part in the study.

3. Have diabetic complications like neuropathy, retinopathy, nephropathy and diabetic foot ulcers.

4. Are undergoing any other complimentary therapies and practicing it.

7.2.5 Instruments intended to be used

The instruments intended to be used in this study are :

· Baseline Proforma.

· One touch ultra glucometer for checking the glycemic level of subjects.

· Tape measure for measuring the height of the subjects.

· Kurup’s weighing apparatus for measuring the weight of the subjects.

· Compliance diary for recording the daily yogic practice session according to date and time.

· Yogic intervention (Vakrasana)

7.2.6 Data collection method

a. Prior to the data collection, permission will be obtained from the concerned authority for conducting the study.

b. Subjects will be selected according to the selected criteria and confidentiality will be assured.

c. Written informed consent will be obtained from the subjects.

d. The investigator will collect the baseline proforma and check the pre intervention glycaemic level and BMI of clients on the day-1 by using the glucometer, weighing machine and tape measure respectively.

e. Experimental group will perform yogic practices (Vakrasana) from the day-2 for one month.

Technique

1. Sit in Dandasana ( sitting sthithi position)

2. Inhale and bent right leg at knee and place right foot beside left knee.

3. Exhale, turn the body to right side, catch hold of right toes with left hand from outside, place right hands on the ground. Right elbow should be straight.

4. Face should be turned to the right side, chin should be in line with the right shoulder. Normal breathing in final posture. Maintain the asana by closing the eyes.

5. Inhale, release the asana and relax for sometimes.

6. Repeat the same from left side.23

f. Client will record the daily yogic practices in the compliance diary.

g. Check the post intervention glycaemic level and BMI values of the experimental group and control group on the 30th, 31st and 32nd day after the intervention of yogic practices.

7.2.7 Plan for data analysis

Data will be analysed by the descriptive and inferential statistical and findings will be presented in the form of tables and figures.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes, yogic interventions will be taught to the clients and blood investigations will be carried out along with BMI measurements to assess the effectiveness of the yogic practice on glycaemic control and BMI since the study design is time series in nature.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes, ethical clearance has been obtained from the ethics committee

8.

Bibliography

1. Smeltzer SC, Bare BG, Hinkle JL, Cheever KH. Brunner and Suddarth’s textbook of medical surgical nursing. 12th ed. Philadelphia: Lippincott Williams and Wilkins Publication; p. 1149-71.

2. http://www.who.int/mediacentre/factsheets/fs312/en/.

3. http://www.changingdiabetesbarometer.com/diabetes-pandemic/a-chronic-disease/diabetes-types.aspx?kwcid=diabetes_type_2_statistics&gclid=COaz2NHcwLICFYZ66wodSwQAow

4. http://www.who.int/mediacentre/factsheets/fs312/en/

5. International Diabetes Federation Atlas 5th ed. IDF 2011. [online]. Available from: URL:http://www.ncbi.nim.nib.gov/pubmed/17496352.

6. Mohan V, Sandeep S, Shah DB, Varghese C. Epidemiology of type 2 diabetes: Indian scenario. Indian Journal of Medical Research 2007;125:217-30.

7. Nair KM, Varghese C. Incidence and prevalence of diabetes in world. [serial online] 2001 [cited 2001 Oct 27]. Available from: URL:http://www.who.com.

8. World Health Organisations statistics on diabetic foot ulcer. [online]. Available from: URL:http://www.asiandiabetes.org/category/asian-diabetes-statistics.

9. www.livestrong.com/.../379217-how-to-control-blood-glucose-levels...

10. Health impacts of yoga and pranayama: a state of the art review. International Journal of Preventive Medicine 2012 Jul;3(7).

11. Jain S. Yogamrutha, Simple yogasanas and pranayamas. India: Shanthivana Trust Publications; P. 84-5,74-5,16-22.

12. Colledge RN, Walker RB, Ralston HS. Davidson’s principles and practices of medicine. 21st ed. Philadelphia: Churchill Livingstone Publications; P. 115.

13. Monroe R, Joyce, Comer A, Nagarathna R, Dona DP. Original research, yoga therapy for NIDDM; a controlled trial.

14. Sreedevi K, Devaki PB, Bhushanam GV. Effect of Siddha Samadhi Yoga on health and nutritional status of normal and diabetic subjects. J Diabetes Metab 2012 Jun;3:195.

15. Ankad RB, Herur A, Patil S, Shashikala GV, Chanagudi S. Effects of short term pranayama and meditation on cardiovascular functions in healthy individuals. Heart Views 2012 Apr-Jun;58-62.

16. A study on effect of yoga and various asanas on obesity, hypertension and dyslipidemia. International Journal of Basic and Applied Medical Sciences ISSN:2277-2103. Jan-Apr;2(1):93-8.

17. Effect of yoga therapy on body mass index and oxidative status, Nitte University Journal of Health Science 2011 Sep;1(1-3):10-4.

18. Devasena I, Narhare P. Effect of yoga heart rate and blood pressure and its clinical significance. International Journal of Biomedical and Medical Research 2011;2(3).

19. Yoga practice for the management of Type II diabetes mellitus in adults: A systematic review. eCAM 2010;7(4):399-408.

20. The health benefits of yoga and exercise: a review of comparison studies. The Journal of Alternative and Complementary Medicine 2010;16(1):3-12.

21. Type 2 diabetes in the young: the evolving epidemic. The International Diabetes Federation Consensus Workshop. [online]. Available from: URL:http://care.diabetesjournals.org/content/27/7/1798.long

22. Yoga: a therapeutic approach, Phys Med Rehabil Clin N Am 2004;15:783-98.

23. Jain S. Yogamrutha: simple yogasanas and pranayamas. India: Shanthivana Trust Publications; P. 41-2.

9.

Signature of the candidate

10.

Remarks of the guide

11.

Name and designation of (in block letters)

11.1 Guide

DR. LARISSA MARTHA SAMS

PRINCIPAL

DEPT. OF MEDICAL SURGICAL NURSING.

LAXMI MEMORIAL COLLEGE OF NURSING, MANGALORE

11.2 Signature

11.3 Co-guide (if any)

MRS. DIANA LOBO

ASSOCIATE PROFESSOR

DEPT. OF MEDICAL SURGICAL NURSING.

LAXMI MEMORIAL COLLEGE OF NURSING, MANGALORE

11.4 Signature

12

12.1 Head of the department

DR. LARISSA MARTHA SAMS

PRINCIPAL

DEPT. OF MEDICAL SURGICAL NURSING.

LAXMI MEMORIAL COLLEGE OF NURSING, MANGALORE

12.2 Signature

13.

13.1Remarks of the Chairman and Principal

13.2Signature

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