| CTRI Number |
CTRI/2025/12/098525 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on impact of Yoga before surgery on improvement of breathing and recovery in smokers undergoing cancer of urinary bladder operation |
|
Scientific Title of Study
|
Impact of Preoperative Yoga Intervention on Short term Perioperative Outcomes in Adult Smokers Undergoing TURBT Surgery A 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 |
Asim ghimire |
| Designation |
JUNIOR RESIDENT (ACADEMICS) |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9897446663 |
| Fax |
|
| Email |
ghimireasim123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Gupta |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8527686660 |
| Fax |
|
| Email |
bhavna.kakkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavna Gupta |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anesthesiology AIIMS Rishikesh Virbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8527686660 |
| Fax |
|
| Email |
bhavna.kakkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRYN -collaborative centre of mind body intervention through yoga in colloboration with AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology AIIMS Rishikesh |
| Address |
Rishikesh ,dehradun ,uttarakhand ,249203, India |
| 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 |
| Asim Ghimire |
All INDIA INSTITUTE OF MEDICAL SCIENCES ,RISHIKESH |
Department of Anaesthesiology,Department of Ayush, Department of Urosurgery
Dehradun
UTTARANCHAL |
9897446663
ghimireasim123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences ,Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
yoga group |
yoga will be done on Two sessions per day for 7 days preoperatively and will be continued till discharge , Each session will lasting approximately 25 minutes . A structured yoga and pranayama regimen, specifically tailored to address the perioperative needs of smokers.
|
| Comparator Agent |
non yoga group |
standard preoperative care without yoga will be provided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
History of smoking: more than or equal to 1 pack-year exposure
Smoking cessation for at least a week
Scheduled for elective transurethral resection of bladder tumour (TURBT) surgery under general anaesthesia
surgically resectable Carcinoma of urinary bladder
Mild, Moderate, Severe chronic obstructive pulmonary disease (COPD) classified as GOLD Stage I, II, III respectively.
|
|
| ExclusionCriteria |
| Details |
Patient refusal or unwillingness to participate
Very Severe COPD (GOLD Stage IV), home oxygen therapy requirement, or oxygen saturation less than 92 percentage on room air
Uncontrolled cardiovascular conditions: recent MI (within 6 months), unstable angina, or decompensated heart failure
Neuromuscular or orthopaedic limitations for yoga
Severe cognitive impairment
Major surgery in the past 3 months and Minor surgery within last 2 weeks
Chronic or regular practitioners of yoga or pranayama
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of preoperative yoga interventions as adjunctive therapies on perioperative pulmonary function, clinical outcomes, and psychological well-being in adult smokers undergoing TURBT surgery under general anaesthesia. |
time line mentioned:
Forced Vital Capacity (FVC)Data collection :
Day 0 (Pre-Yoga, Baseline)
Day of Surgery (Post-Yoga, Pre-Surgery)
Day 1 and Day 3 Post-Surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of perioperative yoga intervention as serial changes in Peak Expiratory Flow Rate and Tidal volume using Wrights spirometer and Breath holding time from baseline to Day 3 postoperatively in adult smokers undergoing TURBT surgery under general anesthesia. |
Timepoints mentioned :
Pulmonary Function & Recovery Parameters: Pulmonary Function (Wright Respirometer) Parameters Assessed:
Tidal Volume (TV) and Peak Expiratory Flow Rate (PEFR)
Data Collection:
Day 0 (Pre-Yoga, Baseline)
Day of Surgery (Post-Yoga, Pre-Surgery)
Day 1 and Day 3 Post-Surgery
Pulmonary Function & Recovery Parameter: Breath Holding Time ie. BHT Assessed
Data Collection:
Day 0 (Pre-Yoga, Baseline)
Day of Surgery (Post-Yoga, Pre-Surgery)
Day 1 and Day 3 Post-Surgery
|
| To assess the impact of preoperative yoga and pranayama on Postoperative clinical outcomes, such as Requirement for supplemental oxygen for more than 4 hours, ICU admission for any respiratory complications, Incidence of postoperative pulmonary complications (PPCs), including pneumonia and respiratory failure in adult smokers undergoing TURBT surgery under general anaesthesia. |
Timepoints mentioned:
Postoperative Respiratory Support Requirements Parameters and complications assessed:
-Need for supplemental oxygen (Yes/No, duration in hours postoperatively)
-ICU admission rate and duration (Yes/No, ICU stay in hours/days)
-Incidence of post operative pulmonary complications such as pneumonia, atelectasis or respiratory failure
Data Collection:
Post-Surgery (Day 1 and Day 3)
|
| To compare patient reported psychological well-being using validated tools ie. Surgical Fear Questionnaire (SFQ) and the State-Trait Anxiety Inventory (STAI) from baseline to day of surgery after preoperative yoga and pranayama in adult smokers undergoing TURBT surgery under general anaesthesia. |
Timepoints mentioned : 1.Surgical Fear Questionnaire (SFQ) (Validated for preoperative fear assessment)
2.State-Trait Anxiety Inventory (STAI) (Validated for perioperative anxiety evaluation)
Data Collection:
Day 0 (Pre-Yoga, Baseline)
Day of Surgery (Post-Yoga, Pre-Surgery)
|
| To assess the impact of perioperative yoga intervention in reduction of inflammation, evaluated by Neutrophil-to-Lymphocyte Ratio (NLR) as a biomarker of surgical stress and systemic inflammation from baseline to post surgery in adult smokers undergoing TURBT surgery under general anaesthesia. |
Timepoints mentioned :
Inflammatory Response (NLR) Outcome Measure:
Neutrophil-to-Lymphocyte Ratio (NLR) (Derived from CBC with differential count)
Data Collection:
Day 0 (Pre-Yoga, Baseline)
Day of Surgery (Post-Yoga, Pre-Surgery)
Post-Surgery
|
|
|
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)
|
18/12/2025 |
| 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="1"
Months="0"
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 pilot randomized controlled trial with two parallel arms aims to assess the impact of preoperative yoga interventions
as adjunctive therapies on perioperative pulmonary function, clinical outcomes,
and psychological well-being in adult smokers undergoing TURBT surgery under
general anaesthesia. Considering it a pilot study sample size was kept 60 and they will be randomized into two groups: an intervention group receiving yoga/pranayama sessions twice daily for 7 days preoperatively (and continued postoperatively after 48 hours until discharge), and a control group receiving standard preoperative care without yoga . Primary outcome will be the change in Forced Vital Capacity (FVC) from baseline to Day 3 postoperatively. Secondary outcomes include tidal volume, peak expiratory flow rate, breath-holding time, incidence of postoperative pulmonary complications, requirement of supplemental oxygen, ICU admission for any respiratory complications, patient reported psychological well being (SFQ, STAI scores), and inflammatory biomarker Neutrophil-to-Lymphocyte Ratio (NLR). |