| CTRI Number |
CTRI/2025/09/094587 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Short-Term Preoperative Yoga on Breathing and Recovery in Women Undergoing Robotic Gynecological Surgery |
|
Scientific Title of Study
|
Immediate preoperative yoga based interventions and risk stratification to enhance recovery and outcomes in robotic gynecological surgery
An open labelled double arm pilot randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pritam Yadav |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
block A, level 6, AIIMS Rishikesh, Virbhadra Marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8278305548 |
| Fax |
|
| Email |
raopritam1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
block A, level 6, AIIMS Rishikesh, Virbhadra Marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
block A, level 6, AIIMS Rishikesh, Virbhadra Marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRYN Fellowship (Central Council For Research In Yoga And Naturopathy), Mind Body Medicine Centre , AIIMS Rishikesh, Virbhadra road , Rishikesh, Uttarakhand, India- 249203 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
N/A |
| 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 |
| Dr Pritam Yadav |
AIIMS Rishikesh |
Main OT complex, Block A, level 6, Department of Anesthesiology
Dehradun
UTTARANCHAL |
8278305548
raopritam1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N70-N77||Inflammatory diseases of female pelvic organs, (2) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Incentive Spirometry |
Everyday patient will undergo standard preoperative care along with lung exercise (incentive spirometery for 6 sessions of 10 breaths each) from 3 days prior to 2 weeks post surgery |
| Intervention |
Yoga Based Intervention |
Timing: 3 days prior to 2 weeks post surgery, twice daily, 30 minutes/session
Techniques: Pranayama, Guided Relaxation, Gentle Movements, Bedside or video-guided as per feasibility
Home sessions initially, then supervised after admission |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patients, age 18–65 years
Elective robotic gynecological surgeries
ASA Grade I and II
Informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient unwillingness or any contraindications to yoga practices like severe respiratory or cardiovascular issues
2. Patients with a history of recent respiratory tract infections or pneumonia within the last two weeks
3. Emergency surgical cases or patients unable to undergo preoperative yoga due to scheduling limitations
4. BMI more than or equal to 30
5. Regular yoga practitioner or athlete.
6. Patients with a history of cognitive impairment or psychiatric disorders that may affect their ability to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative Respiratory Parameters (FVC, tidal volume, respiratory rate) via Wright Respirometer |
Before starting of intervention, in preoperative room, 24hours postoperatively and after 2weeks post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety by STAI |
pre intervention and in preoperative room |
| Postoperative pain by NRS |
6, 12, 24 hr post operatively |
| Analgesic consumption |
first 48h |
Time to ambulation
|
started walking first time postoperatively |
| Return of bowel function |
Flatus or faeces passing first time post operatively |
| Hospital discharge time |
days to discharge |
Wound healing
(suture removal) |
time to suture removal |
Nutrition
(NRI, BMI, Serum albumin, Hemoglobin) |
Pre intervention, 24 hr postoperative and 2 weeks postoperatively |
Inflammatory markers
NLR |
Pre intervention, 24 hr postoperative and 2 weeks postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/10/2025 |
| 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="1"
Months="4"
Days="0" |
|
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 thesis aims to assess the effects of short-term yoga on respiratory function and recovery in women undergoing robotic gynecological surgeries. These surgeries can impair lung function due to factors like pneumoperitoneum and patient positioning, leading to complications such as atelectasis, increased anxiety, and delayed recovery. Yoga, especially pranayama and breathing exercises, has shown benefits in improving lung capacity, reducing stress, and enhancing respiratory muscles. This study involves two groups: one receiving standard care with incentive spirometry, and the other receiving additional yoga sessions over three days before surgery. Outcomes measured include lung function (using Wright respirometer), anxiety, pain, recovery milestones, wound healing, nutrition, inflammation, and patient satisfaction. The hypothesis is that yoga will improve pulmonary rehabilitation and psychological readiness, resulting in better recovery compared to standard care. The study uses a randomized controlled design with a total of 60 participants. Expected benefits are improved lung function, reduced anxiety and pain, faster recovery, enhanced wound healing, and shorter hospital stays. This research explores yoga as an adjunctive, non-pharmacological intervention to optimize perioperative care in robotic gynecological surgery. |