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Yoga As An Intervention For Caregivers Of In-Patients With Traumatic Injury: A Randomised Controlled Trial

Phase 2
Not yet recruiting
Conditions
Stress (PSS Score 14 or more)
Registration Number
CTRI/2019/03/018220
Lead Sponsor
Centre for Integrative Medicine and Research
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria
  • (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.
Exclusion Criteria
  • (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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
(1) Caregiver Self Assessment QuestionnaireBaseline, 1 Month, 3 Months
(2) Depression Anxiety Stress Scale 21Baseline, 1 Month, 3 Months
(3) Perceived Stress ScaleBaseline, 1 Month, 3 Months
Secondary Outcome Measures
NameTimeMethod
WHOQOL-BREFBaseline and 3 Months

Trial Locations

Locations (1)

AIIMS Delhi

🇮🇳

Delhi, DELHI, India

AIIMS Delhi
🇮🇳Delhi, DELHI, India
Dr Rajesh Malhotra
Principal investigator
91-9990020044
rmalhotra62@gmail.com

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