This study is designed to be a prospective, single centre, interventional controlled study

 Primary Objective

1.      To evaluate the effect of Bhaktivedanta mantra and music audio therapy on infants and parent of infants.

2.      To evaluate the effect of mantra meditation and 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 and PSS NICU scale scores.

4.      To evaluate the changes in neonatal pain assessment score in infants.

      Secondary Objective:

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.

The eligible patient will be assigned to either control or interventional group using simple randomization technique.

     Study Intervention:

1.      The study intervention includes mantras which are pre-recorded in a radio device, which comprises of the following mentioned mantras:

·         Aditya Hriday kavacha strotram

·         Dhanvantari mantra

·         Hare Krishna mantra

·         Narasimha kavacha

·         Varaha kavacha 

Study procedures: Study procedures will began post obtaining both Parent/Legal Guardian consent for infant participation as well as Participant (Parent) Consent.

I. For Interventional Group: Mantra Based Audio Therapy + Standard of Care

A.    For Parent of Infant:

1.      Post voluntary consent from the parent, he/she will be explained about importance of spiritual mantra practices and will be guided to hear pre-recorded Bhaktivedanta Mantras twice a day for 30 mins from a radio device.  

2.      The parent development will be assessed through following scales/questionnaire:

·         PSS NICU scale

·         GAD questionnaire

3.      The above-mentioned scales and questionnaire will be assessed at following timepoints:

·         At the timepoint of day 1 of enrolment.

·         At the timepoint of day of discharge of infant from NICU.

4.      Mantras to be heard as an intervention for parent include the following: 

·         Aditya Hriday kavacha strotram

·         Dhanvantari mantra

·         Hare Krishna mantra

·         Narasimha kavacha

·         Varaha kavacha 

5.      The duration of parent participation will be from the timepoint of admission of infant in the NICU till the timepoint the infant gets shifted from NICU.

B.     For Infants:

1.      Post voluntary consent from Parent/Legal Gaurdian, very slow volume mantras will be played with a radio device for 8 hrs which will be placed beside NICU bed of infant and the study team will monitor the progress of infant in terms of Weight gain, Feed tolerance, Heart rate, Irritability, Desaturation episodes.

2.      The infant’s development will be assessed based on following scale:

·         Neonatal pain assessment

3.      The above-mentioned scale will be assessed at following timepoints:

·         Neonatal pain assessment: At the timepoint of alternate days i.e (day 2,4,6,8,10…n) from the day of enrolment to the timepoint infants is admitted in NICU.

4.      Mantras to be heard as an intervention for both infants include the following: 

·         Aditya kavacha strotram

·         Dhanvantari mantra

·         Hare Krishna mantra

·         Narasimha kavacha

·         Varaha kavacha 

5.      The duration of infant participation will be from the timepoint of admission of infant in the NICU till the timepoint the infant gets shifted from NICU.

II. For Control Group:

·         Infants assigned in this group will be given only standard of care and will not receive mantra-based audio therapy.

·         Parent assigned in this group will not receive mantra audio therapy.

Schedule of activities-Parent

Schedule of activities- Infants