| CTRI Number |
CTRI/2025/07/091142 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Therapeutic Impact of Yogic Techniques on Pre-Operative Stress. |
|
Scientific Title of Study
|
Assessing the Therapeutic Impact of Yogic Techniques on Pre-Operative Stress: A Pilot Study. |
| Trial Acronym |
N/A |
|
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 |
7054750162 |
| Fax |
|
| Email |
rkj41a@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Kuldeep Kumar Pandey |
| Designation |
Prof. & Head |
| 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 |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| 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 |
7054750162 |
| Fax |
|
| Email |
rkj41a@bhu.ac.in |
|
|
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 Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh 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 BHU |
Department of sangyaharan Faculty of Ayurveda 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: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: F01-F09||Mental disorders due to known physiological conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Arm (Non Ayurveda) |
Standard pre-operative care without structured stress interventions. With mesurement by Physiological GSR, heart rate, and blood pressure baseline and post-intervention. Psychological DASS 42 administered pre and post intervention. |
| 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 by 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.No prior yoga experience.
2. People who can read at least as well as a sixth grade.
3. Both genders.
4. People who undergo Surgery.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with a history of neurologic disease.
2. Known case of psychiatric disease.
3. Known cases of Renal failure, Paralysis, Parkinson’s disease, severe anaemia, and Malignancy, Pregnant and Lactating females, Syphilis, AIDS, and Leprosy disorders.
4. Those who are unable to perform yogic practices.
5. Emergency surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dass questionnaire (Stress)
GSR Reading
|
20 to 25 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
20/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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.
|