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CTRI Number  CTRI/2023/09/057438 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 08/03/2024
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   Integrative Yoga for Caregivers of paediatric patients undergoing Cardiac Surgery. 
Scientific Title of Study   Effect of Integrative Yoga on Psychological Outcomes & inflammatory Biomarkers in Caregivers of Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial. 
Trial Acronym  YOGPSE Trial. 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anu James Vibin 
Designation  Nursing Officer 
Affiliation  All India Institute of Medical Sciences 
Address  Center for Integrative Medicine and Research, 7th floor, room no. 7001, convergence block building, All India Institute of Medical Sciences, New Delhi.

New Delhi
DELHI
110029
India 
Phone  8860574642  
Fax    
Email  anujamesvibin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Natesh Babu 
Designation  Deputy Director, CODE SVYASA 
Affiliation  SVYASA Bangalore 
Address  Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore

Bangalore
KARNATAKA
560105
India 
Phone  9342825813  
Fax    
Email  natesh.babu@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Anu James Vibin 
Designation  Nursing Officer 
Affiliation  All India Institute of Medical Sciences 
Address  Center for Integrative Medicine and Research, 7th floor, room no. 7001, convergence block building, All India Institute of Medical Sciences, New Delhi.

New Delhi
DELHI
110029
India 
Phone  8860574642  
Fax    
Email  anujamesvibin@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 110029 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 
Anu James Vibin  All India Institute of Medical Sciences  Centre for Integrative Medicine and Research, All India Institute of Medical Sciences, Room No.7004 Convergence Block New Delhi-110029
South
DELHI 		 8860574642

anujamesvibin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active control group  Participants randomized to the control arm may have an interest in yoga. In order to clear the possible disappointment and possible nocebo effects related to the allocation process, Nurse-led counseling sessions will be given by the licensed Nursing officer of the hospital to the control group in the Center for Integrative Medicine and Research (CIMR) at AIIMS, New Delhi. These classes will include modules on topics like stress and its management, the Importance of diet and sleep Physical exercise and grooming, and General care of the child post-surgery. Interactive dialogue will be encouraged between the instructor and participants. They will get, 4 Nurse-led counseling sessions for 20 min once weekly for 4 weeks. 
Intervention  Intervention Group  Yoga intervention will be performed at the Centre for Integrative Medicine and Research (CIMR) at AIIMS, New Delhi. Participants assigned to the Intervention group shall undergo the integrative yoga intervention, which comprises of practices like Loosening Exercises, physical postures (ASANAS) pranayama (controlled breathing), and deep relaxation therapy. The supervised yoga intervention will be given under the guidance of an institutionally certified yoga therapist. The physical postures consist of preliminary stretching exercises followed by breathing exercises and then by asana in four categories (standing, sitting, prone, and supine). Participants will be instructed to follow a specific breathing pattern during each asana. The yoga asana will be practiced with awareness focused primarily on their physical movements and respiration. Each posture will be followed by an appropriate relaxation therapy. For relaxation, patients will be encouraged to put emphasis on breathing. This yoga program would include all direct contact sessions. Every session will have a pre-planned curriculum which will facilitate adherence and secure repeatability of the intervention. Participants will be given booklets and will be encouraged to practice daily or at least with a frequency of 5 sessions per week. Compliance will be reinforced with log book and weekly telephonic assessments will be done to check for reassuring adherence to the study trial. 4 weeks of 40 min yoga for 5 days a week + 4 Nurse-led counseling sessions for 20 min once a week.  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Caregivers aged between 22 to 45 years
2. Caregivers of those children (aged 0-11 years, birth to middle childhood as per National Institute of child health and human development NICHD) undergoing surgery, will be recruited within 24 hours prior to the planned surgery.

3. Caregivers of children undergoing any cardiac surgery like- BD Glenn, ASO, ASD closure, VSD closure, COA repair, TOF repair, Truncus Arteriosus Repair, Tricuspid Atresia Repair, PDA Ligation, Switch Surgery, BT shunt, Total Correction.
4. HAM-A scale ranging from 18-30.
5. Caregivers willing and able to participate in the study.
6. Caregivers giving written informed consent.
 
 
ExclusionCriteria 
Details  1. Caregivers who are ill or with any neurological illness, physical deformity, any illnesses whose participation will hinder the outcomes are not eligible to participate in the trial.
2. Patients were excluded if they had non correctable hearing loss or any diagnosed or untreated Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) Axis I diagnosis (e.g., schizophrenia, bipolar disorder, or active substance use disorder).
3. Pregnant females
4. HAM-A scale ranging from 0-17 and 31-56
5. Regular yoga Practitioner for the last 3 months.
 
 
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 
Caregiver Anxiety as measured by the Hamilton anxiety rating scale  At baseline & at the end of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Caregiver burden as measured by CAREGIVERS BURDEN SCALE- INDIAN POPULATION

 		 At baseline & at the end of 4 weeks 
Caregiver Resilience as measured by Brief Resilience Scale  At baseline & at the end of 4 weeks 
Caregiver Quality of life as measured by World health organization Quality of life  At baseline & at the end of 4 weeks 
Caregiver blood parameters as measured by IL6, D-Dimer, CRP, & cortisol levels  At baseline & at the end of 4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3 
Date of First Enrollment (India)   16/09/2023 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anujamesvibin@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study design will be a prospective, randomized, open, blinded end point (PROBE) trial. The study will be conducted under the Centre for Integrated Medicine and Research (CIMR), AIIMS. The subjects will be recruited from AIIMS cardiac ICU’s wards and waiting areas. All referred patients will be screened as per the HAM-A tool and once the eligibility criteria will be fulfilled informed consent will be taken. Patients will be recruited for the study and baseline evaluation will be done. 

Group allocation will be performed with a mixed block randomization method by computer-generated random sequence from sealed envelop.com. After generating a random sequence, allocation-concealment will be done by sequentially numbered opaque sealed envelopes. Participants will be then randomized in an allocation ratio of 1: 1 to the Intervention group and Active control group. 

The intervention group will receive Integrative yoga along with a Nurse-led counseling session whereas the active control group will receive only a Nurse-led counseling session. Assessment will be done at baseline and Post-intervention at the completion of 4 weeks. The intervention will be given by trained yoga instructors who are nursing officers at CIMR over a period of 4 weeks. Compliance will be ensured with a logbook and telephonic assessments.

4 weeks of 40 min yoga for 5 days a week + 4 Nurse-led counseling sessions for 20 min once a week.

 
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