| CTRI Number |
CTRI/2019/03/018220 [Registered on: 22/03/2019] Trial Registered Prospectively |
| Last Modified On: |
22/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga As An Intervention For Caregivers Of In-Patients With Traumatic Injury: A Randomised Controlled Trial |
|
Scientific Title of Study
|
Yoga As An Intervention For The Family Caregivers Of In-Patients With Traumatic Injury: A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Malhotra |
| Designation |
PROFESSOR & HEAD Department of Orthopaedics Chief, J P N Apex Trauma Centre |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
91-9990020044 |
| Fax |
91-11-26589093 |
| Email |
rmalhotra62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Malhotra |
| Designation |
PROFESSOR & HEAD Department of Orthopaedics Chief, J P N Apex Trauma Centre |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
91-9990020044 |
| Fax |
91-11-26589093 |
| Email |
rmalhotra62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Malhotra |
| Designation |
PROFESSOR & HEAD Department of Orthopaedics Chief, J P N Apex Trauma Centre |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
91-9990020044 |
| Fax |
91-11-26589093 |
| Email |
rmalhotra62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Centre for Integrative Medicine and Research |
| Address |
Centre for Integrative Medicine and Research, Room 7004, Seventh floor, Convergence Block, All India Institute of Medical Sciences, New Delhi-110029 |
| Type of Sponsor |
Other [Research Centre in Government Medical Institution] |
|
|
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 Rajesh Malhotra |
AIIMS Delhi |
Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
91-9990020044
91-11-26589093
rmalhotra62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress (PSS Score 14 or more) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No additional activity for the Control group |
No additional activity for the Control group |
| Intervention |
Yoga |
Participants will practice a yoga module consisting of Breathing exercises, Asana, Pranayama, and mainly Relaxation techniques for a duration of 30 minutes. After the practice there will be group counselling based on selected concepts of Yoga philosophy only for the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(1) First-degree relative caregiver/attendant identified by the consultant in charge as likely to be in
≥ 2 weeks.
(2) Caregivers of in-patients with trauma-induced injuries who are newly admitted in JPN Apex Trauma Centre, All India Institute of Medical Sciences (AIIMS), New Delhi.
(3) Spends 5-8 (<) hours a day (5 days) with the patient.
(4) Perceived Stress Scale score above 14.
(5) Be older than 18 years old.
(6) Caregivers who can communicate freely in Hindi or English.
(7) Be willing and physically able to participate in a physical activity intervention.
(8) Be willing to not initiate any other physical activity during the intervention. |
|
| ExclusionCriteria |
| Details |
(1) Paid caregivers employed for assisting.
(2) If the patient is discharged within 5 days of admission.
(3) Previously enrolled in a clinical trial about the caregiving experience or yoga or currently is part of another study.
(4) Any illness which restricts the individual for yoga (neurological disorder, cardiovascular disease, respiratory/ endocrine disorders, or any major psychiatric illness).
(5) Frequent alcohol or recreational drug use.
(6) Any yoga practice in the previous 3 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Caregiver Self Assessment Questionnaire
(2) Depression Anxiety Stress Scale 21
(3) Perceived Stress Scale |
Baseline, 1 Month, 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHOQOL-BREF |
Baseline and 3 Months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2019 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No such publications yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anxiety, stress and depression in caregivers of trauma/head injury patients is a genuine problem. Providing services to caregivers can result in improved outcomes for people with traumatic injury, as well as improving caregiver depression, health and problem-solving. Yoga has been found to be effective in the management of stress, anxiety, and depression. The study aims at studying the effectiveness of yoga on caregiver burden, anxiety and quality of life of the primary family caregivers. Our hypothesis is that practising yoga will help in reducing the caregiver burden and anxiety in primary family caregivers.
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