Integrative Yoga for Caregivers of paediatric patients undergoing Cardiac Surgery.

Phase 3

Recruiting

Brief Summary: Thestudy design will be a prospective, randomized, open, blinded end point (PROBE) trial. The study will beconducted under the Centre for Integrated Medicine and Research (CIMR), AIIMS. Thesubjects will be recruited from AIIMS cardiac ICUâ€™s wards and waiting areas. Allreferred patients will be screened as per the HAM-A tool and once the eligibilitycriteria will be fulfilled informed consent will be taken. Patients will berecruited for the study and baseline evaluation will be done.

Groupallocation will be performed with a mixed block randomization method bycomputer-generated random sequence from [sealed envelop.com](http://sealedenvelop.com/). After generating a randomsequence, allocation-concealment will be done by sequentially numbered opaquesealed 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 sessionwhereas the active control group will receive only a Nurse-led counseling session.Assessment will be done at baseline and Post-intervention at the completion of4 weeks. The intervention will be given by trained yoga instructors who arenursing officers at CIMR over a period of 4 weeks. Compliance will be ensuredwith 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.

Recruitment & Eligibility

Inclusion Criteria

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.
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.
HAM-A scale ranging from 18-30.
Caregivers willing and able to participate in the study.
Caregivers giving written informed consent.

Exclusion Criteria

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.
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).
Pregnant females 4.
HAM-A scale ranging from 0-17 and 31-56 5.
Regular yoga Practitioner for the last 3 months.

Primary Outcome Measures

Name	Time	Method
Caregiver Anxiety as measured by the Hamilton anxiety rating scale	At baseline & at the end of 4 weeks

Secondary Outcome Measures

Name	Time	Method
Caregiver Quality of life as measured by World health organization Quality of life	At baseline & at the end of 4 weeks
Caregiver burden as measured by CAREGIVERS BURDEN SCALE- INDIAN POPULATION
Caregiver Resilience as measured by Brief Resilience Scale	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

Locations (1): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
Anu James Vibin
Principal investigator
8860574642
anujamesvibin@gmail.com