| CTRI Number |
CTRI/2025/05/086455 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Breath holding Exercises (Buteyko Breathing) plus Muscular Relaxation Method on Stress Levels of the Physiotherapy Students |
|
Scientific Title of Study
|
EFFECT OF BUTEYKO BREATHING TECHNIQUE AND JACOBSONS RELAXATION EXERCISE ON STRESS LEVELS OF THE PHYSICAL THERAPY STUDENTS |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy, Punjabi University, Patiala
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417802490 |
| Fax |
|
| Email |
sandyraina248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy, Punjabi University, Patiala
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417802490 |
| Fax |
|
| Email |
sandyraina248@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy, Punjabi University, Patiala
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417802490 |
| Fax |
|
| Email |
sandyraina248@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Punjabi University, Patiala, Punjab, India,147001 |
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
NO |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ankita Gupta |
Punjabi University, Patiala |
Department of physiotherapy,OPD1 and OPD2, Punjabi university, Patiala
Patiala
PUNJAB |
08558849103
ag726511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Punjabi University, Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko Breathing Technique
Jacobsons Relaxation Exercise |
4 weeks, one session, thrice a week |
| Comparator Agent |
Jacobsons Relaxation Exercise |
4 weeks, one session, thrice a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Physical therapy students
Score of more than or equal to 20 as by the perceived stress scale
Score of more than or equal to 12 by general health questionnaire-12 |
|
| ExclusionCriteria |
| Details |
a) Individuals with cardiopulmonary disorders such as COPD.
b) Taking any medication such as anti-depressants or anxiolytic.
c) Practicing any relaxation technique such as yoga and meditation
d) Subjects who smokes or having any substance addiction.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Perceived Stress Scale -10 |
At baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
General Health Questionnaire-12
Blood Pressure |
At baseline, at 4th week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to assess the effectiveness of Buteyko breathing technique and Jacobson’s relaxation exercise on stress levels among physical therapy students aged 18-25. Participants will be randomly divided into experimental and control groups, receiving four weeks of treatment sessions. The findings will help broaden the scope of physiotherapy in treating stress and related conditions. |