DISSERTATION PROTOCOL

1
 NAME OF THE Mrs. AMUTHA.S
1. CANDIDATE AND W/O Mr. JEGAN.P,
ADDRESS NO:21/25,MAVARAVILLI,
KALLANKUZHI POST,
K.K. DIST.

HINA COLLEGE OF NURSING

NAME OF THE
2. YELAHANKA NEW TOWN,
INSTITUTION
BANGALORE-560064

M.Sc NURSING,
COURSE OF STUDY AND
3. (MEDICAL- SURGICAL
SUBJECT
NURSING)

DATE OF ADMISSION
4. 05/06/ 2009
TO THE COURSE

5. TITLE OF THE TOPIC:-

“ASSESS THE EFFECTIVENESS OF STRUCTURED

TEACHING PROGRAMME ON KNOWLEDGE OF
PREVENTION OF HYPOGLYCEMIA AMONG DIABETIC
PATIENTS IN OUT PATIENT DEPARTMENT OF SELECTED
HOSPITALS IN BANGALORE”.

6. BRIEF RESUME OF INTENTED WORK

6.1: NEED FOR THE STUDY:-

Hypoglycemia occurs when the blood glucose falls to less than 50 to 60
mg/dl. It can be caused by too much insulin, or oral hypoglycaemic agent, too
little food, or excessive physical activity1.

2
 The prevalence of hypoglycaemia from 1980 to 2002, a total of 1465
patients (8.8%) had at least 1 episode of hypoglycemia. Of these patients, 1002
(68.5%) had 1 episode, 252 (18%) had 2 episodes, and 203 (13.5%) had 3 or
more episodes.8 In a longitudinal cohort study of 16,667 elderly (mean age 65
years) patients with type 2 diabetes, 1465 patients (8.8%) had at least one
episode of hypoglycemia and in that 1.26 for one episode 1.80 for two episodes
and 1.94 for three or more episodes.10
A retrospective study conducted among 20,000 older diabetic subjects
regarding hypoglycemia with risk factors of treating insulin, sulfonylureas
showed an incidence of severe hypoglycemia of 1.23 per 100 patient years with
sulfonylureas and 2.76per 100 patient years with insulin therapy .In 1998, the
UK Prospective Diabetic Survey reported a prevalence of severe hypoglycemia
of 0.4% in chlorpropamide treated patients with type 2 diabetes over
approximately 10 years follow-up, with a prevalence of 0.6% seen in those
people on glibenclamide.15
According to National Urban Diabetes Survey (NUDS), based on WHO
criteria, the prevalence of diabetes is rapidly rising all over the globe at an
alarming rate. In world wide, the standardized prevalence of type 2 diabetes
was 12.1 per cent. In the southern part of India to be higher-13.5 per cent in
Chennai, 12.4 per cent in Bangalore, and 16.6 per cent in Hyderabad; compared
to eastern India (Kolkata), 11.7 percent; northern India (New Delhi), 11.6 per
cent; and western India (Mumbai), 9.3 per cent.12
A random survey study conducted regarding hypoglycemia events of
type 1 and type 2 diabetes over a 4 weeks period and 267 samples were
included in this study. In those 267 subjects, 155 reported 572 incidents of
hypoglycemia. The type1 diabetic subjects reported a rate of 43events per
patient per year, whereas subjects with type 2 diabetes reported a rate of 16
events per patient per year2.
A cross-sectional study was carried out on the diabetic patients attending
the out patient clinic at Karnataka state in India in 2007. Patients' level of
knowledge was assessed by asking questions on symptoms of hypoglycemia

3
and Knowledge about hypoglycemia was considered to be adequate if the
patient could correctly recall three of the following hypoglycemic symptoms:
sweating, palpitations, hunger, tremor or feeling of impending disaster, each of
which can be relieved by taking some food or glucose. A total of 342 diabetics
were studied; 191(56%) of the respondents had adequate knowledge about the
symptoms of hypoglycemia. Men were found to be more aware than women
and this difference was statistically significant. The present study has shown
that diabetics in the area under study had a poor level of knowledge about the
disease and complication6.
A study conducted in Singapore demonstrated that diabetes education
had changed the knowledge among diabetics toward a more effective self-care
In this study, only 52 (51.5%) patients actually knew the symptoms of
hypoglycemia. However, 77 (76.2%) patients knew that they should consume
sweets if theyhad experienced an episode of hypoglycemia. This shows that the
knowledge of diabetes in patients is only partial and that most patients may not
be able to take appropriate corrective measures sufficiently early and may seek
medical aid only at very late stages5.
Further, the investigator concluded that it would be a useful contribution
and it is important to improve the knowledge of diabetic patients in maintaining
their glucose levels. Hence, the investigator plans to design the structured
teaching programme on knowledge of prevention of hypoglycemia among
diabetic patients.

6.2: REVIEW OF LITERATURE:-

A hypoglycemic reaction usually comes on very suddenly. It often
happens at the time when insulin action is at its peak, during or after strenuous
exercise or when a meal is delayed. A study conducted regarding fear of
hypoglycaemia in patients with diabetes. Fear of Hypoglycemia appears to be a

4
widespread phenomenon. It is measured primarily through the use of a specific
scale, the Hypoglycemic Fear Survey (HFS). There are a number of factors that
relate to whether an individual is likely to develop Fear of Hypoglycemia
including whether there is a history of hypoglycemia in an individual, length of
time since first insulin treatment, and a higher level of variability in blood
glucose level. Such fear can be reduced with blood glucose awareness training
(BGAT) or cognitive behavioural therapy (CBT).17.
A study concluded among 164 patients with type 1 diabetes who either
had a severe hypoglycaemic episode in the previous year or had impaired
hypoglycaemia awareness, the severe hypoglycemic episode (Hypos)
programme was compared with a standard education programme. After 6
months, hypoglycaemia awareness improved the threshold for detection of low
blood glucose and treatment of low blood glucose increased, and the number of
undetected hypoglycaemic episodes and the rate of mild hypoglycaemia
decreased more in the severe hypoglycemic episode ( Hypos) group than the
control group 4.
A research study estimated that incidence of sulfonylureas induced
hypoglycemia at 0.19-0.25 per 1000 patient years, much lower than the
incidence of approximately 100 per 1000 patient years for hypoglycemia in
type1 diabetic subjects treated with insulin therapy. These episodes of
sulfonylureas induced hypoglycemia quoted almost 25 years ago refer to severe
hypoglycemia, during which the patients were often unconscious and requiring
hospital treatment. Sulfonylureas induced hypoglycemia was more common in
everyday clinical practice, reported that 20% of people with type 2 diabetes,
aged 45-65 years and treated with sulfonylureas, had at least one episode of
symptomatic hypoglycemia in the preceding 6 months; 6% of these subjects
experienced symptoms on a monthly basis7.
A two year prospective case finding study involving 300 patients with
type 1 diabetes 16% of patient’s had a symptomatic hypoglycemia event
usually during sleep 6-16 hours after strenuous exercise18.

5
 According TO WHO the message of World Diabetes Day 2009 in their
call for greater understanding and taking control of diabetes. Managing
diabetes, while minimizing hypoglycemia, is a key treatment goal in the
pharmacological control of diabetes. Effective education on recognizing the
signs and symptoms of hypoglycemia is crucial. It is essential that people with
diabetes, and their friends and family, know the best way to treat a
hypoglycemic attack, as swift action to administer oral carbohydrate or
injectable glucagon can quickly resolve a hypoglycemic episode, before
requiring paramedic help or hospital admission14.

A study was conducted regarding prevention of hypoglycaemia by using

either an optimized subcutaneous insulin regime or continuous insulin regime
can restore hypoglycaemia awareness in Type 1 diabetes. Following a 6-day
continuous subcutaneous monitor glucose profile, participants will be
randomized to 1 of 3 interventions rigorous avoidance of hypoglycaemia on
current insulin regime; targeted optimization of subcutaneous insulin regime to
avoid hypoglycaemia; or continuous subcutaneous insulin infusion.
Symptomatic experience and severity of hypoglycaemia, pattern of
hypoglycaemia on glucose profiling and, in selected individuals, response to
hyperinsulinaemic hypoglycemic clamp, will be compared over a 6 month
period. It is envisaged that successful prevention of hypoglycaemia by one or
more interventions may reverse altered hypoglycaemia awareness and prevent
further episodes of severe hypoglycaemia16.

A study reported that, flexible Intensive Insulin Therapy in Adults with

Type 1 Diabetes and High Risk for Severe Hypoglycemia found that a
reduction from 6.1 to 4.7 (95% CI ±0.2) hypoglycemic events per patient per
year may be due to regression to the mean. However, there would still remain a
reduction from 4.7 to 1.4 hypoglycemic events per patient per year, which was
of clinical importance in this high-risk population9.

6
 A total of 92 Type 2 diabetes mellitus (T2DM) patients receiving
sulfonylurea and reporting drug-associated hypoglycemia, and 84 T2DM
patients receiving sulfonylurea and having never experienced hypoglycemia
were included in the study A total of 11 out of 92 subjects (12%) experiencing
hypoglycemia as opposed to only 1 out of 84 subjects (1.2%) free of
sulfonylurea-induced hypoglycemia11.

A research study conducted regarding blood glucose self monitoring

among patients with diabetes in family medicine practise. There were 91
patients with the type 2 diabetes who completed six months education about
their disease. The patients who did or did not do self-monitoring with
glucometer were interviewed on knowledge about recognizing and resolving
hypoglycemia and, 3 months after reading the brochure (passive education) and
additional 3 months of group (intensive) education. Out of 91 interviewed
patients, there were 29 who did self-monitoring by glucometer at the beginning
of the education, 30 patients during the passive education and 34 after the
group education. At the end of education, their knowledge was better at both
recognizing and resolving hypoglycemia (P=0.01)3.

A study identified that the threat and incidence of hypoglycemia is the

major limiting factor in intensive glycemic control for both type 1and type 2
diabetes. If mild or moderate hypoglycemia isn't treated promptly, it can turn
into severe hypoglycemia. People with severe hypoglycemia have so little
sugar in their system that it affects their brain. When that happens, they can
enter a diabetic coma. The best way to avoid severe hypoglycemia is catch it
early. Be alert to any symptoms of hypoglycemia .So education of patient is
very important issue in today’s clinical practice2.

Education regarding all aspects of diabetes care is important to prevent

complications. Hypoglycemia is problematic in type1 diabetes during
aggressive glycemic therapy and in advanced type 2 diabetes because of
compromised glucose counter regulatory systems. Therefore, education

7
concerning self-monitoring of blood glucose, diet, physiological insulin
replacement, medication, and lifestyle are important to maintain good glycemic
control, avoid hypoglycemia, and prevent long-term complications.

6.3: STATEMENT OF PROBLEM

“Assess the effectiveness of structured teaching programme on
knowledge of prevention of hypoglycemia among diabetic patients in
outpatient department of selected hospitals in Bangalore”.
6.4: OBJECTIVES OF THE STUDY:
1. To assess the level of knowledge of diabetic patients regarding
prevention of hypoglycemia.
2. To evaluate the effectiveness of structured teaching programme on
knowledge of diabetic patients regarding prevention of
hypoglycemia.
3. To determine the association between the knowledge of prevention
of hypoglycemia among diabetic patients with their demographic
variables.
6.5: HYPOTHESIS:
H0: Their will be no difference between pre tests and post tests
knowledge scores of diabetic patients regarding prevention of hypoglycaemia.
H1: There will be significant association between demographic variables
with knowledge of diabetic patients.
6.6: OPERATIONAL DEFINITIONS:
ASSESS:
It is the measurement of knowledge of diabetic patients regarding
prevention of hypoglycemia by structured interview schedule.
EFFECTIVENESS:
It refers to an extent to which the structured teaching programme on
prevention of hypoglycemia achieves the desired effect in improving the
knowledge of diabetic patients.

8
STRUCTURED TEACHING PROGRAMME:
It refers to the systematically developed instructional method and
teaching aids designed for diabetic patients to provide information regarding
prevention of hypoglycemia.
KNOWLEDGE:
It refers the amount of information or awareness of diabetic patients
regarding the prevention of hypoglycemia which is explored by the score of
structured interview schedule.

PREVENTION:
The term prevention is reserved for those interventions that occur before
the initial onset of disorder.
HYPOGLYCEMIA:
It refers to a low blood sugar level less than 60mg/dl in blood.

DIABETIC PATIENTS:
Patients who is diagnosed with Diabetes mellitus and having regular
check up with the doctor.

6.7: ASSUMPTION:
1) Diabetic patients will be having some knowledge regarding
prevention of hypoglycemia.
2) Structured teaching programme will enhance the knowledge of the
diabetic patients regarding prevention of hypoglycemia.
3) The knowledge of the diabetic patients will vary from one individual
to another individual.
7. MATERIALS AND METHODS:
7.1: SOURCES OF DATA:
Diabetic patients in out patient department of selected hospitals in
Bangalore.

9
7.2: METHODS OF COLLECTING DATA:
Data will be collected by the investigator herself by using structured
interview schedule.
7.2.1: PERIOD OF DATA COLLECTION:
Data will be collected in the month of September-October 2010.
7.2.2: RESEARCH DESIGN AND APPROACH:
The research design adopted for this study will be quasi experimental
design in which one group pre and post test approach without control group.
7.2.3: SETTING
The study will be conducted in outpatient department of selected
hospitals in Bangalore.
7.2.4: POPULATION
The population of the present study will be diabetic patient who is
attending out patient department of selected hospitals at Bangalore.
7.2.5: SAMPLE SIZE
The sample size will be 50.
7.2.6: SAMPLING TECHNIQUE
Purposive sampling technique will be used to select the sample for the
study.
7.2.7: SAMPLING CRITERIA
INCLUSIVE CRITERIA:
Diabetic patients who are,
 available in out patient department during data collection.
 able to understand and speak in Kannada and English.
 willing to participate in the study.
 both male and female diabetic patients.
EXCLUSIVE CRITERIA:
Diabetic patients who are,
 not available in out patient department during data collection.
 not able to understand and speak in Kannada and English.

10
  not willing to participate in this study.
7.2.8: DATA COLLECTION TOOL
Structured interview schedule will be prepared and used for the data
collection.
7.2.9 DATA ANALYSIS METHOD
 Appropriate descriptive and inferential statistics will be used for
data analysis and presented in the form of table, graph, figure etc.
 The effectiveness of pre and post test score of knowledge will be
analyzed by paired ‘T” test.
 The significance of relationship between the selected demographic
variables and knowledge of scores will be analyzed by using chi-
square test.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR

INTERVENTION TO BE CONDUTED ON OTHER HUMANS OR
ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY.
-NO-
7.4 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM
YOUR INSTITUTION IN CASE OF 7.3?
Ethical clearance will be obtained from the authority before conducting
the research study.

8. LIST OF REFERENCES:-
1. Brunner & Suddarth’s. Textbook of Medical-Surgical Nursing, 10th edition,
Lippincott Company, 2003, page no: 1178-1179.

11
2. Donnelly et al. Frequency &predictors of hypoglycemia in type 1and insulin
treatment type 2 diabetes, A population based study, 2005, 22:749-755.
3. Herenda S, Tahirović H. Blood glucose self-monitoring among patients with
diabetes mellitus type 2 in family medicine practice, 2009, 62(7-8):342-5
4. Hermanns et al. The effect of an education programme (Hypos) to treat
hypoglycaemia problems in patients with type 1 diabetes, Diabetes Metab
Res,2007, 23: 528–38.
5. Michell Gulabani et al. Knowledge of diabetes &complication among
diabetic patients in tertiary care hospital, Indian journal of community
medicine, volume: 23, 2008.
6. Dr J P, Majra et al. Awareness Regarding Self Care among Diabetics in Rural
India, middle east journal of family medicine, volume: 7, 2009.
7. Page KA. Williamson A. Type 1 diabetic patients during acute
hypoglycemia, Diabetes, 2009, 58(5):1237-44.
8. Pauline Anderson. Hypoglycemia in type 2 Diabetes, The journal of
American medical association, 2009, 301:1565-1572.
9. Pennant et al. Flexible Intensive Insulin Therapy in Adults with Type 1
Diabetes and High Risk for Severe Hypoglycemia, American diabetic
association, 2007,356:1970–1974.
10. Rachel A. Whitmer, PhD, et al. Hypoglycemia episodes in older patients
with type 2 diabetes mellitus, The journal of American medical
association,2009,301(15):1565-1572.
11. Ragia.G.Pedtridis, Increases risk for hypoglycemia in Type 2 diabetic
patients treated with sulfonylureas, 2009, 10(11):178; 1-7
12. Ramachandran A, et al. Diabetes Epidemiology Study Group in India
(DESI). High prevalence of diabetes and impaired glucose tolerance in India:
National Urban Diabetes Survey. Diabetologia, 2001, 44:1094-101
13. Shorr RI, et al. Incidence and risk factors for serious hypoglycaemia in
older persons are using insulin or sulfonylureas, Arch Intern Med, 1997,
157:1681-6.

12
14. Simon J. et al. Hypoglycemia Prevention and Treatment, On-line journal
Diabetic Hypoglycemia calls for greater understanding and taking control of
diabetes, 2009, 345-56.
15. UK Prospective Diabetes Study (UKPDS) Group, Intensive blood glucose
control with sulphonylureas or insulin compared with conventional treatment
and risk of complications in type 2 diabetes (UKPDS 33)1998, 352:837-53
16. Vanessa J Briscoe et al. Hypoglycemia in type 1&type 2 Diabetes, Clinical
Diabetes,Volume:24, 2006,2456-67.
17. Wild et al. A critical review of the literature on fear of hypoglycemia in
diabetes: implications for diabetes management and patient education, Patient
Education& Counseling, Oxford outcomes Ltd, 2007, 68: 10–15.
18. William .V.Tamborlane. Prevention of hypoglycemia during exercise in
type 1 diabetes, 2005, 28:2948–2961

13
 SIGNATURE OF THE
9.
STUDENT:-

REMARKS OF THE GUIDE:-

10.
The study is useful to improve the knowledge of diabetic patients. The
need for the study and methodology is appropriate and as per the
statement of the problem. Hence, the study can be undertaken.
Mrs.FAIROZA M
NAME AND
11. Associate professor & H.O.D
DESIGNATION
OF THE GUIDE:- Medical-Surgical Nursing.

GUIDE SIGNATURE:
11.1

11.2 HEAD OF THE Mrs.FAIROZA M

DEPARTMENT: Associate professor & H.O.D
Medical-Surgical Nursing.

SIGNATURE:
11.3

REMARKS OF THE CHAIRMAN AND PRINCIPAL:

12.1
This helps to improve the knowledge of diabetic patients and it is
approved by the research committee.Hence, can be conducted.

SIGNATURE:
12.2

14