| CTRI Number |
CTRI/2025/12/098647 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of buteyko breathing on stress and sleep quality in younger adults with migraine |
|
Scientific Title of Study
|
Effect Of Buteyko Breathing Technique as an adjuvant to standard Medical Treatment on Perceived Stress,Quality of Life and Sleep Quality in Younger Adults with Migraine Disability - A Quasi Experimental Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riddhi Jain |
| Designation |
intern |
| Affiliation |
PES Modern college of physiotherapy shivajinagar pune-411005 |
| Address |
Department of Cardiovascular & Respiratory Physiotherapy, PES Modern College of Physiotherapy OPD, PES Modern College, Shivajinagar,Pune-05 PES Modern College of Physiotherapy OPD, PES Modern College, Shivajinagar,Pune-05 Pune MAHARASHTRA 411005 India |
| Phone |
8856912571 |
| Fax |
|
| Email |
riddhideepakjain@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shruti Mankar |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor PES Modern college of physiotherapy shivajinagar pune-411005 |
| Address |
PES Modern College of Physiotherapy Shivajinagar Pune 05
Pune MAHARASHTRA 411005 India |
| Phone |
7276020635 |
| Fax |
|
| Email |
mankarshrutee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Riddhi Jain |
| Designation |
intern |
| Affiliation |
PES Modern college of physiotherapy shivajinagar pune-411005 |
| Address |
Department of Cardiovascular & Respiratory Physiotherapy,
PES Modern College of Physiotherapy, Pune -05
Pune MAHARASHTRA 411005 India |
| Phone |
8856912571 |
| Fax |
|
| Email |
riddhideepakjain@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| PES Modern college of Physiotherapy OPD, PES Modern college of Physiotherapy, Pune-05 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Riddhi jain |
PES Modern college of physiotherapy |
Department of Cardiovascular & Respiratory Physiotherapy Physiotherapy OPD Shivajinagar Pune -05,Maharashtra India. Pune MAHARASHTRA |
08856912571
riddhideepakjain@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee PES Modern College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko breathing technique |
buteyko breathing technique are breath retraining exercises which consist of nasal breathing low volume breathing and control pause
buteyko breathing has been used in hypertension asthama and stress
Duration of exercise for 3 times per week for 4 weeks ,session duration of 20-25 minutes |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-25 years
Diagnosed with migraine by department of neuro medicine since 6 months and more
Patients on medicine both symptomatic and prophylactic
Patients with mild to moderate disability scores ranging from 6 to 20 on MIDAS
Patients who score moderate to high i.e scores ranging from 15 to 40 on PSS-10
Patients with PSQI score more than 5
Patient willing to be part of this study
Patient willing to practice exercise at home
|
|
| ExclusionCriteria |
| Details |
Patient with any neurological condition which hinder communication with patient
Patient with active respiratory infection
Patient with any cardiovascular disorder
Patient with recent abdominal surgery or organ transplant
Pregnant females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percieved stress scale
Migraine specific quality of life
Pittsburg sleep quality index |
Pre- intervention
at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Migraine Disability assessment test |
pre-intervention
at the end of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
17/12/2025 |
| 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="5" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to evaluate the effectiveness of the Buteyko Breathing Technique on perceived stress, sleep quality, and quality of life in young adults with migraine related disability. Migraine is influenced by stress and disturbed sleep, and these factors can worsen migraine frequency and symptom severity. The Buteyko Breathing Technique uses slow nasal breathing and control pause training to reduce sympathetic overactivation and stabilize carbon dioxide levels. These physiological changes may help decrease chronic hyperventilation, promote relaxation, and improve autonomic balance.
Participants aged 18 to 25 years who have mild to moderate migraine disability and score in the moderate or high range on the Perceived Stress Scale and poor sleep quality that is score more than 5 on Pittsburgh sleep quality index will be included. All participants will undergo baseline assessment using the Perceived Stress Scale, Pittsburgh Sleep Quality Index, and the Migraine Specific Quality of Life Questionnaire. The intervention will consist of Buteyko Breathing Technique sessions for four weeks for 3 days in a week twice a day for twenty minutes
After the intervention, the same outcome measures will be repeated to compare pre and post intervention changes. The study will help determine whether Buteyko Breathing Technique can be used as a safe and cost effective method to reduce stress, improve sleep quality, and improve migraine related quality of life in young adults. |