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To check the effect of Bhaktivedanta mantra audio therapy on infants in Neonatal Intensive care unit & their parents in a tertiary care institute.

A prospective, two arm, single centre, controlled, interventional study to assess the effect of Bhaktivedanta mantra audio therapy on infants in Neonatal Intensive care unit & their parents in a tertiary care institute.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054366
Enrollment
100
Registered
2023-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: O134- Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth

Interventions

Intervention1: Spiritual Care Intervention: The study intervention includes mantras which are pre-recorded in a radio device, which comprises of the following mentioned mantras: •Aditya Hriday kavacha

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • For Infants: 1.Infants with Postconceptional age of 29–35 weeks at birth (the reason for including gestational age of more than 29 weeks was that the auditory structure of the foetus was completed at 25 weeks and could respond appropriately to auditory stimuli after 28 weeks). 2.Infants to be included after 3 days of postnatal age. 3.Infants for whom consent provided by parents. • For parent of infants: 1.All genders. 2.Age should be more than 18 years. 3.Parent who are willing to participate in the compliance of the study.

Exclusion criteria

Exclusion criteria: • For Infants: 1.Infants with cardiorespiratory instability. 2.Infants under Intubation in NICU. • For parent of infants: 1.Parent who does not voluntarily consent to participate in the study. 2.Parent with impaired hearing disorder.

Design outcomes

Primary

MeasureTime frame
1. To evaluate the effect of Bhaktivedanta mantra, music audio therapy on infants, parent of infants. 2. To evaluate the effect of mantra meditation, audio therapy on stress levels of parents of infants in NICU. 3. To determine the level of stress experienced by parents of babies admitted by NICU by assessing the changes in GAD, PSS NICU scale scores. 4. To evaluate the changes in neonatal pain assessment score in infants. Timepoint: 1. At the timepoint of day 1 of enrolment. 2. At the timepoint of day of discharge of infant from NICU.—

Secondary

MeasureTime frame
1. To evaluate the changes in heart rate in infants. 2. To evaluate whether the pacifier is needed or not. 3. To evaluate the feeding tolerance. Timepoint: 1. At the timepoint of day 1 of enrolment. 2. At the timepoint of day of discharge of infant from NICU.—

Countries

India

Contacts

Public ContactDr Komal Dalal

Bhaktivedanta Hospital and Research Institute

drkomal@bhaktivedantahospital.com9324611434

Outcome results

None listed

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