CHAPTER 3

METHODOLOGY

Research methodology involves the systematic process by which the research

starts from initial identification of problem to its final construction.1
This chapter deals with research design, setting of the study, population,
sample, sampling technique, sample selection criteria, tool and technique, validity and
reliability, pilot study, data collection process and plan for data analysis. The present
study was aimed to assess the effect of structured teaching programme on knowledge
and practice regarding oral anticoagulant therapy among patients attending a tertiary
care hospital in Thiruvananthapuram.

Research approach

Quantitative approach

Research design

The research design adopted for the study is Pre-experimental one group pre-test and
post test design.

O1 X O2

O1 – Pre test

X – Intervention (Structured teaching programme)

O2 – Post test

Variables

Dependent variables, independent variables and extraneous variables were

considered in this study.

Dependent variables

Knowledge and practice regarding oral anticoagulant therapy

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Independent variables

The presumed cause is referred to as independent variable. 1 In this study;

structured teaching programme on oral anticoagulant therapy is the independent
variable.

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 Setting and Sample, sample size, Tool and Expected
population sampling technique Technique Data Analysis
Outcome

Sample Pre-test
Patients Structured Descriptive
Setting receiving oral questionnaire and statistics Improvement in
Ananthapuri
anticoagulant rating scale to assess Frequency, knowledge and
Hospitals and therapy the knowledge and percentage, mean practice
Research Institute Ananthapuri
practice regarding oral and standard regarding oral
Thiruvananthapura Hospitals and deviation
anticoagulant therapy anticoagulant
m Research
Institute. therapy among
patients

Intervention

Structural teaching
Sampling programme on
technique: knowledge and practice Inferential
Population
purposive regarding oral statistics
sampling anticoagulant therapy Paired-
Patients receiving
oral anticoagulant t- test
therapy Post test

Sample size Structured questionnaire

and rating scale regarding
70 oral anticoagulant therapy

Figure 2: Schematic representation on the study design

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Setting of the study

a) The study was conducted in OP, wards and ICU’s in Ananthapuri Hospitals
And Research Institute

Population

Patients receiving oral anticoagulant therapy.

Sample

Patients receiving oral anticoagulant therapy admitted in Ananthapuri

Hospitals And Research Institute.

Sample size

Sample size is 70

Sample size is calculated by the formula

n = Zα2×p(1-p)

d2

Zα = Z statistics for a level of confidence

p = Estimated proportion of an attribute present in the population

d = Level of precision

Zα = 1.96

p = 0.6 (proportion of average knowledge regarding anticoagulant therapy among

stroke survivors)2

d = 20% of p

d = 20/100×0.6 = 0.12

n = (1.96)2×0.6×(1-0.6) = 66.6

(0.12)2

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Sample size is 70

Sample technique

Purposive sampling technique was used for the present study.

Inclusion Criteria

 Patient receiving oral anticoagulant therapy in the age group of 18 years and
above
 Patient receiving oral anticoagulant therapy for more than three month.

Exclusion Criteria

 Patient with cognitive impairment

 Patient who is critically ill
 Those who are not willing to participate
 Patients new to anticoagulant therapy

Tool and Technique

Tool 1 :- Structured questionnaire consists of two sections:

Section A: Socio demographic data

Section B: Clinical Data

Section C: Questionnaire to assess the knowledge regarding oral anticoagulant

therapy

Part A: Knowledge regarding general information regarding oral anticoagulant

therapy.

Part B: Knowledge regarding Administration of oral anticoagulants

Part C: Knowledge regarding interactions of oral anticoagulants.

Part D: Knowledge regarding side effects and diet of oral anticoagulant

therapy.

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 Part E: INR monitoring

Part F: Precautions during anticoagulant therapy

Tool 2 :- Rating scale to assess the practice regarding oral anticoagulant therapy

It consists of 15 questions which consist of positive and negative statements.

Technique

Self-reporting

Development of the tool

The initial draft of the tool was prepared by the investigator to elicit the socio

demographic data, knowledge and practice regarding oral anticoagulant therapy on

the basis of literature reviews and suggestions from the experts in the field of

cardiology, cardiovascular and thoracic surgery, pharmacology, statistics, Medical

Surgical Nursing and language experts. The tool was translated to Malayalam and was

back translated to English.

Description of the tool

1. Structured questionnaire consist of 2 sections.

Section A: Socio demographic data includes 15 questions regarding: age, gender,

education, occupation, monthly income, marital status, religion, type of family, diet,
area of residence, adverse health habits, previous knowledge regarding oral
anticoagulant therapy, family history of oral anticoagulant therapy, and family history
of cardiovascular disease or stroke.

Section B: clinical data of the patient which includes 11 questions: diagnosis,

comorbidities, list of medications other than oral anticoagulant, name of the oral
anticoagulant, dose of oral anticoagulant, duration of oral anticoagulant therapy,

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frequency of checking INR, target INR, recent INR value, TTR value and any side
effects experienced.

Section C: structured questionnaire to assess the knowledge regarding the oral

anticoagulant therapy. It consists of 35 questions which are under the following.

Sl. no Domains Question number

General information regarding oral anticoagulant 1-4

1.
therapy.
2. Administration of oral anticoagulants 5-9

3. Interactions of oral anticoagulants 10-13

4. Side effects and diet of oral anticoagulant therapy 14-20

5. INR monitoring 21-25

6. Precautions during anticoagulant therapy 26-35

Each question carries one mark with the total score of 35. The grading of the

knowledge score as follows

Grading

Marks Percentage Grading

26-35 >75% Good knowledge

17-25 50-75% Average knowledge

1-16 <50% Poor knowledge

2. Rating scale consisting of negative and positive statements

Rating scale consists of 15 statements, which have 7 positive and 8 negative

statements. Participants can mark the responses as always, sometimes, and never.

Each statement carries maximum of +1 marks. Positive statements marked as 3 to 1

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forward and negative statements reversely. The total score allotted for rating scale is

45.

Grading of the practice can be done by taking the median from the pre and

post test score. Below the median consider as negative practice and greater the median

consider as positive practice.

Intervention

Development of the structured teaching programme

The investigator prepared a structured teaching plan regarding the oral

anticoagulant therapy based on literature review. The content validity of the teaching

plan was done by experts in the field of cardiology, cardiovascular and thoracic

surgery, pharmacology, statistics, and language experts. After editing, the final draft

of the structured teaching plan was prepared.

Description of the structured teaching programme

Structured teaching programme was conducted to the participants by using

the structured teaching plan and Liquid Crystal Display (LCD). It includes description

about the general information regarding oral anticoagulant therapy, administration of

oral anticoagulants, interactions of oral anticoagulants, side effects and diet during

oral anticoagulant therapy, INR monitoring and precautions during oral anticoagulant

therapy. The duration of the teaching programme was 25-30 minutes.

A booklet containing brief description about the all aspects of oral

anticoagulant therapy like general information regarding oral anticoagulant therapy,

administration of oral anticoagulants, interactions of oral anticoagulants, side effects

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and diet during oral anticoagulant therapy, INR monitoring and precautions during

oral anticoagulant therapy were given to the participants after the structured teaching

programme.

Content validity

After developing the tool, content validity was done by experts in the field of

cardiology, cardiovascular and thoracic surgery, pharmacology, statistics, and

language experts. Necessary corrections suggested by the experts were considered and

modified accordingly. The tools were given for Malayalam and were retranslated to

English, confirmed clarity and the tool was found to be valid.

Reliability of the tool

The reliability of the tool was established by Split half method and r value is

0.861. Hence the tool is a reliable for measuring knowledge and practice regarding

oral anticoagulant therapy among patients.

Pilot study

After getting permission from the Institutional ethical committee and

concerned authority of Ananthapuri Hospitals and Research Institute,

Thiruvananthapuram, pilot study was conducted among 7 subjects, to assess the

feasibility of the study. Data on knowledge and practice regarding oral anticoagulant

therapy were obtained by using structured questionnaire and rating scale, and then the

structured teaching programme was administered by using LCD to all the participants.

The duration of the teaching programme was 25-30 minutes. After seven days, post

test was conducted for the participants with poor knowledge and practice score. Data

was analysed by using descriptive and inferential statistics.

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Data collection process

After getting permission from the ethical committee and concerned authority

of Ananthapuri Hospitals and Research Institute, Thiruvananthapuram, those who

meet the inclusion criteria were contacted and consent for participating the study was

obtained. A pre test was conducted to assess the knowledge and practice regarding

oral anticoagulant therapy with structured questionnaire and rating scale. 25-30

minutes were taken for pre test, which was conducted.

After the pre test, the structured teaching programme was conducted with the

help of LCD, for all the participants on the same day. The knowledge and practice

regarding the oral anticoagulant therapy was assessed and the knowledge and practice

level of the participants were categorized as poor, average, good, excellent. To

evaluate the effect of structured teaching programme on knowledge and practice

regarding oral anticoagulant therapy, participants will poor awareness scores were

selected. A post test was conducted after 1 month using the same questionnaire used

for the pre-test.

Plan for data analysis

Descriptive statistics was used to describe the data by using mean, standard

deviation, percentage and frequency distribution.

Inferential statistics: chi square test to find out the association between socio

demographic variables and paired t test was used for evaluating the effect of

structured teaching programme on knowledge and practice regarding oral

anticoagulant therapy among patients.

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 This chapter dealt with the methodology used for the study. Next chapter will

deal with analysis and interpretation of the data.

Reference

1. Pilot D F, Beck CT. Nursing Research: Generating and assessing evidence for

Nursing practice. 9th edition. Philadelphia: Wolkers Kluwer; 2011:51-54, 94,

268-269.

2. Jinu Joseph , Saramma ,Sylaja. Assessment of knowledge regarding oral

anticoagulant therapy among stroke survivors. The nursing Journal of

India.2018 ;( 6):253-256.

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