| CTRI Number |
CTRI/2025/05/086577 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of yoga-based breathing and relaxation regimen on preoperative anxiety and stress biomarkers in patients undergoing neurosurgery |
Scientific Title of Study
Modification(s)
|
Effect of yoga-based breathing and relaxation regimen on preoperative anxiety and neurological biomarkers in neurosurgical patients: A prospective 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 Nidhi Singh |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow |
| Address |
Department of Anaesthesiology,
Sanjay Gandhi Postgraduate
Institute of Medical Sciences (SGPGIMS),
Raebareli Road,
Lucknow
UTTAR PRADESH
226014
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9501522330 |
| Fax |
|
| Email |
nidhisingh22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow |
| Address |
Department of Anaesthesiology,
Sanjay Gandhi Postgraduate
Institute of Medical Sciences (SGPGIMS),
Raebareli Road,
Lucknow,
Uttar Pradesh
226014
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9501522330 |
| Fax |
|
| Email |
nidhisingh22@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow |
| Address |
Department of Anaesthesiology,
Sanjay Gandhi Postgraduate
Institute of Medical Sciences (SGPGIMS),
Raebareli Road,
Lucknow,
Uttar Pradesh
226014
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9501522330 |
| Fax |
|
| Email |
nidhisingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Raebareli Road, Lucknow, India, Pin code: 226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences SGPGIMS Lucknow |
| Address |
Department of Anaesthesiology Sanjay Gandhi Postgraduate
Institute of Medical Sciences Raebareli Road Lucknow 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nidhi Singh |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Department of Anaesthesiology Block A
Lucknow UTTAR PRADESH |
9501522330
nidhisingh22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sanjay Gandhi Postgraduate |
Approved |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences, 140th Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C71||Malignant neoplasm of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C (Control) |
Patients in this group will not receive any yogic breathing and relaxation practices. They will receive routine medical care based on their clinical needs upon admission to the pre-operative wards. |
| Intervention |
Group Y (Yogic breathing) |
Patients in this group will receive yoga-based breathing and relaxation regimes for 5 days before undergoing elective supratentorial glioma excision. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I or II adult patients (aged 18-65 years) of either sex
2. Conscious patients who are oriented to time, place, and person with GCS 15/15 scheduled for elective craniotomy and excision of supratentorial tumors under general anesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patient/patient attendants unwilling to give consent
2. Patients experiencing significant mass effect such as headache, nausea, vomiting, photophobia, drowsiness, or any other signs of raised intracranial pressure
3. Patients with motor sensory deficit
4. Patients with hearing or vision impairment
5. Patients with tumor-induced seizures who are uncontrolled on weight-appropriate antiepileptic medication
6. Severe pulmonary disorders i.e., restrictive or obstructive lung disease
7. Severe coronary artery disease or heart failure
8. Smoking or alcohol abuse
9. Psychiatric disorder
10. Emergency surgery
11. Patients with recurrent tumors for re-do surgery
12. Patients with significant skeletal or joint disorders hindering them from performing the relevant yoga postures/ techniques
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of a short-term yoga-based breathing regimen on preoperative anxiety, using the State-Trait Anxiety Inventory (STAI) |
Before surgery |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. To evaluate the impact of yoga-based breathing & relaxation practices, continued into the postoperative period, on serum biomarkers including GFAP (Glial Fibrillary Acidic Protein), NfL (Neurofilament Light), S100beta, & BDNF (Brain Derived Neurotropic Factor) at 6 weeks. 2. To explore the feasibility & adherence of supervised tele-yoga sessions in the perioperative care of neurosurgical patients. |
6 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80" Sample Size from India="80"
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)
|
10/07/2025 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Preoperative anxiety, affecting 17% to 89% of brain surgery patients, can result in longer hospital stays, depression, increased physical disability, reduced quality of life, and impaired cognitive functions. Conventional antianxiety drugs like opioids and benzodiazepines worsen the problem by causing hypoventilation and raising intracranial pressure. This has led to a focus on nonpharmacological interventions that avoid these adverse effects. Yoga is a promising therapeutic tool for managing physical, psychological, and psychosomatic disorders. Studies in cardiac surgery patients and breast cancer survivors have demonstrated the efficacy of yoga-based lifestyle programs and breathing exercises. Yoga has been linked to physiological and biochemical benefits. This study explores the potential benefits of incorporating yoga-based breathing and relaxation techniques into the perioperative care of neurosurgical patients. We hypothesize that neurosurgical patients scheduled for elective supratentorial tumor excision who practice yoga-based breathing exercises for about five days preoperatively will experience reduced preoperative anxiety compared to those who do not. Research Question: Does a short-term yoga-based breathing regimen reduce preoperative anxiety in neurosurgical patients compared to those who do not practice yoga? Primary Objective: To determine the effect of a short-term yoga-based breathing regimen on preoperative anxiety, using the State-Trait Anxiety Inventory (STAI). Secondary Objective: To determine the impact of an extended yoga-based breathing regimen, continued into the postoperative period, on neurological biomarkers such as glial fibrillary acidic protein (GFAP), neurofilament light (NfL), S100B and brain-derived neurotropic factor (BDNF), and to explore the feasibility and adherence of supervised tele-yoga sessions in perioperative care of neurosurgical patients. This prospective randomized controlled trial will be conducted on 80 patients (40 in each group) in the Neurosurgical wards of Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow. The study will include adult patients (aged 18-65 years) scheduled for elective craniotomy and excision of supratentorial tumors under general anesthesia. The study will include ASA I or II patients who are conscious and oriented. Patients unwilling to consent, those with significant mass effect or tumor-induced seizures, severe pulmonary or coronary artery disease, smoking or alcohol abuse, psychiatric disorders, emergency surgeries, and significant skeletal or joint disorders will be excluded. Group Y (Yoga) patients will receive yoga-based breathing and relaxation regimes for at least five days before surgery and Group C (Control) patients will not receive yoga interventions while receiving usual medical care. A night before surgery, anxiety scores (STAI) will be assessed in all the patients (Primary outcome). At six weeks of discharge, GFAP, NfL, S100B and BDNF will be measured. |