| CTRI Number |
CTRI/2025/07/091815 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Designing and Testing a Stress Relief Program Before Operation |
|
Scientific Title of Study
|
Designing, Validation, and Feasibility of a Yoga-Based Intervention for Pre Operative Stress |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
Dept. Of sangya haran FoA IMS BHU |
| Address |
Department of sangyaharan Faculty of Ayurveda Institute of Medical science BHU. 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07054750162 |
| Fax |
|
| Email |
rkj41a@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohit |
| Designation |
Research Scholar |
| Affiliation |
Dept. of Sangya haran FoA IMS BHU |
| Address |
Department of sangyaharan Faculty of Ayurveda Institute of Medical science BHU. 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08958066049 |
| Fax |
|
| Email |
mohitkumar.dsvv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit |
| Designation |
Research Scholar |
| Affiliation |
Dept. of Sangya haran FoA IMS BHU |
| Address |
Department of sangyaharan Faculty of Ayurveda Institute of Medical science BHU. 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08958066049 |
| Fax |
|
| Email |
mohitkumar.dsvv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 15/16A Department of Sangyaharan Faculty of Ayurveda IMS BHU 221005 |
|
|
Primary Sponsor
|
| Name |
Sir Sundar lal Hospital Banaras Hindu University |
| Address |
Room no 15/16A Department of Sangyaharan Faculty of Ayurveda IMS BHU 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Rakesh Kumar Jaiswal |
Sir Sundar Lal Hospital IMS |
Room No. 15 16A Ayurveda Faculty Department of sangyaharan, Institute of Medical science BHU. 221005
Varanasi
UTTAR PRADESH |
07054750162
rkj41a@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F06||Other mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Arm |
Standard pre-operative care without structured stress interventions as yoga Practices With mesurement by Physiological GSR, heart rate, blood pressure baseline and DASS 42 Stress measurement
questionnaire. |
| Intervention |
Two Arm Compare Study |
Daily 25-minute sessions (20-22 days pre-surgery) including Om Chanting, asanas (Vajarasana, Makrasana), pranayama (Bhramari ), and mindfulness meditation (Yoga-Nidra). with measurement Physiological GSR, heart rate, and blood pressure baseline and post-intervention. Psychological DASS 42 administered pre and post intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. People who must undergo surgery.
2. For people who can read at least as well as a sixth grader.
3. Both genders.
4. Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with a history of neurologic disease.
2. Known case of psychiatric disease.
3. Those who are unable to perform yogic practices
4. Emergency surgery.
5. Known cases of Renal failure, Paralysis, Parkinson’s disease, severe Anemia, and Malignancy, Pregnant and Lactating females, Syphilis, AIDS, Leprosy, and Bleeding disorder.
Those who are unable to perform yogic practices.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dass Questionnaire (Stress) 42
BP
GSR Reading
SPo2 |
20-22 Days |
|
|
Secondary Outcome
|
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/08/2025 |
| 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="0"
Days="25" |
|
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
|
Compare stress levels between the Yoga and control groups. Assess the correlation between physiological and psychological stress indicators. Anticipate significant reductions in GSR, DASS-42 scores, and cardiovascular parameters in the Yoga group, supporting feasibility for a larger trial. Results will inform integrative approaches to pre-operative care. |