TOPIC: RESEARCH METHODOLODY FOR A STUDY ON EFFICAC Y OF
CHORMOTHERAPY, MUD T HERAPY, ACUPUNCTURE & ACUP RESSURE IN
REDUCING HYPERACTIVITY AND INCREAS ING CONCE NTRATION IN 4 12 AGE GROUP CHILDRE N ALONG WITH 20 MIN GUIDED MEDITATION
This Methodology is for study on effect of Yoga & Relaxation technique in reducing stress and
lowering blood pressure in hypertensive patients.
METHODOLOGY
In methodologyPermission
Study settingSampling- Size and design
Inclusion and exclusion criteria
Operational definitions
Armamentarium/tools
Methodology
Gantt chart
Analysis
1. Study Design:
The current trial will be Randomized Controlled Trial to assess the efficacy of Yoga and
Relaxation technique in reducing stress and lowering blood pressure in Grade 1 and
Grade 2 hypertensive patients. This will be two arm ( Yoga & Relaxation Technique +
usual care Vs Usual Care alone) parallel Randomized controlled trial. The duration of the
study is of 2 months with 24 sessions of interventions. It will be open labeled.
2. Study Setting:
The study is carried out in one allopathic hospital and one in Naturopathy and Yoga
centre. Assessments were carried out in respective hospitals.
3. Sample Size:
150 participants aged between 35-55 yrs both male and female were included in the
study, chosen to ensure sufficient statistical power to detect a moderate effect size
(Cohen’s d = 0.5) with 95% confidence and 80% power. The sample size was calculated
using the formula:
n=(Zα/2+Zβ)2⋅2σ2d2n = \frac{(Z_{\alpha/2} + Z_\beta)^2 \cdot 2\sigma^2}{d^2}n=d2(Zα/2
+Zβ)2⋅2σ2
Reference: Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences.
4. Sampling Technique:
A simple random sampling technique ( probability method) will be used to ensure the
study population represents different demographic segments (age, gender, occupation).
Participants will be randomly assigned to either the intervention or control group using
computer-generated random numbers.
5. Selection Method:
Recruitment: Participants will be recruited by local advertisements, from online platforms
and also through referrals.
Participants will be selected based on inclusion & exclusion criteria mentioned below.
Inclusion criteria:
a) Adults aged between 35-55 yrs who have been diagnosed as grade 1or grade 2
Hypertension within a period of 6 months
b) Those who do not practice Yoga or any of the relaxation technique
c) Those who agree to provide a written informed voluntary consent
Exclusion criteria:
a) Individuals with any comorbid disease or mobility limitations or physical
disabilities that prevent participation in Yoga
b) Those who are migrants will not be included as they may not come for follow-up
c) Those who do not understand language English &/or Hindi medium of instruction
for Yoga and relaxation technique.
6. Operational Definition:
1. Grade 1 Hypertension is a stage of high blood pressure where the systolic blood
pressure (SBP) is between 140-159mm Hg and/or the diastolic blood pressure (DBP)
is between 90-99mm Hg.
2. Grade 2 Hypertension is a stage of high blood pressure where the systolic blood
pressure (SBP) is between 160-179mm Hg and/or the diastolic blood pressure (DBP)
is between 100-109mm Hg.
3. According to WHO, Stress can be defined as a state of worry or mental tension
caused by a difficult situation. Stress is a natural human response that prompts us to
address challenges and threats in our lives.
7. Methods of Data Collection :
Primary Data collection:
1. Blood Pressure is measured using sphygmomanometer .
2. Stress Reduction Measured by changes in perceived stress levels using the Perceived
Stress Scale (PSS).
Secondary Data collection:
1. Mental Well-being: Assessed through the General Health Questionnaire (GHQ-12) to
evaluate psychological well-being and mood.
2. Quality of Life: Assessed using the SF-36 Health Survey.
3. Sleep Quality: Evaluated using the Pittsburgh Sleep Quality Index (PSQI).
Timing of Assessments

Baseline (Week 0): Initial assessment of all outcome measures before the intervention
begins.

Midpoint (Week 4): Interim evaluation to monitor progress and make any necessary
adjustments after completing 12 sessions.

Post-Intervention (Week 8): Final assessment to measure the primary and secondary
outcomes after completing the 24 sessions program.

Follow-up (Week 12): A follow-up assessment to evaluate the long-term effects and
sustainability of the intervention.
8. Data Analysis:
Statistical Methods
 Descriptive Statistics: Used to summarize the baseline characteristics of the
participants (e.g., age, gender, baseline stress levels) in both intervention and control
groups. This will include means, standard deviations, frequencies, and percentages.
 Inferential Statistics:
o Paired t-tests: To compare pre- and post-intervention outcomes within each group.
o Independent t-tests: To compare outcomes between the intervention and control
groups.
o ANOVA: For analyzing differences in outcomes across multiple time points (baseline,
midpoint, post-intervention, and follow-up).
o Regression Analysis: To examine the relationship between the intervention (yoga and
relaxation) and outcomes (e.g., stress reduction), controlling for confounding variables
like age, gender, or baseline health status.
Software
 SPSS (Statistical Package for the Social Sciences) will be used for the data analysis due
to its robust capabilities for handling complex datasets and various statistical tests.
 R: For more advanced statistical modeling and data visualization, R may also be used,
especially for subgroup analyses and handling missing data.
FLOWCHART:
1.Planning & Approval
2.Protocol Writing
3.Need For the Study
4. Aim & Objectives
5.Literature Review
6.Methodology
7. Participant Recruitment & Selection (Randomization)
8. Baseline Data Collection
9. Intervention
Reference Group
Standard Care
Experimental Group
Weekly thrice Yoga sessions & Relaxation Technique
For 24 sessions in 2 months period
10.Data Collection
11.Data Analysis
12.Reporting & Dissemination