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Integrative Yoga for Caregivers of paediatric patients undergoing Cardiac Surgery.

Effect of Integrative Yoga on Psychological Outcomes & inflammatory Biomarkers in Caregivers of Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial. - YOGPSE Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057438
Enrollment
50
Registered
2023-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 s

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Caregiver Anxiety as measured by the Hamilton anxiety rating scaleTimepoint: At baseline & at the end of 4 weeks

Secondary

MeasureTime frame
Caregiver blood parameters as measured by IL6, D-Dimer, CRP, & cortisol levelsTimepoint: At baseline & at the end of 4 weeks;Caregiver burden as measured by CAREGIVERS BURDEN SCALE- INDIAN POPULATION Timepoint: At baseline & at the end of 4 weeks;Caregiver Quality of life as measured by World health organization Quality of lifeTimepoint: At baseline & at the end of 4 weeks;Caregiver Resilience as measured by Brief Resilience ScaleTimepoint: At baseline & at the end of 4 weeks

Countries

India

Contacts

Public ContactAnu James Vibin

SVYASA Bangalore

natesh.babu@svyasa.edu.in9342825813

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026