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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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