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

Not Applicable

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

Registration Number: CTRI/2023/06/054366

Lead Sponsor: Bhaktivedanta Hospital and Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate the effect of Bhaktivedanta mantra, music audio therapy on infants, parent of infants. <br/ ><br>2. To evaluate the effect of mantra meditation, audio therapy on stress levels of parents of infants in NICU. <br/ ><br>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. <br/ ><br>4. To evaluate the changes in neonatal pain assessment score in infants. <br/ ><br>Timepoint: 1. At the timepoint of day 1 of enrolment. <br/ ><br>2. At the timepoint of day of discharge of infant from NICU.

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the changes in heart rate in infants. <br/ ><br>2. To evaluate whether the pacifier is needed or not. <br/ ><br>3. To evaluate the feeding tolerance. <br/ ><br>Timepoint: 1. At the timepoint of day 1 of enrolment. <br/ ><br>2. At the timepoint of day of discharge of infant from NICU.