Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour

Phase 4

Completed

• Conditions: Normal Healthy Term Appropriate-for-date Newborn
• Interventions: Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)

• Registration Number: NCT01278329
• Lead Sponsor: NSCB Medical College

Brief Summary

Auditory stimulation during pregnancy has been found to influence foetal behaviour with a potential of being carried forward to neonatal period. This study evaluated the effect of ante-natal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns. This was a single centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol violations. The infants born to mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation and habituation.

Conclusion:

Music exposure to mother during pregnancy significantly influences neonatal behaviour.

Detailed Description

Objective:

Auditory stimulation during pregnancy has been found to influence foetal behaviour with a potential of being carried forward to neonatal period. This study evaluated the effect of ante-natal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS).

Methods:

This was a single centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol.

Results:

One hundred and 26 newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants born to mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82-1.44, p\<0.0001) and habituation (ES 1.05, 95% CI 0.53-1.57, p=0.0001).

Conclusion:

Music exposure to mother during pregnancy significantly influences neonatal behaviour.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2010-12
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 339

Inclusion Criteria

• All consecutive primigravida mothers of 19 to 29 years of age with singleton pregnancy attending the ante-natal clinic of the study institution first time, before 20 weeks of gestation were eligible for inclusion.

Exclusion Criteria

• Mothers with significant co-existing medical diseases or severe to profound hearing loss were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music	"Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)	Mothers in the music group were provided a pre-recorded "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India) with a running duration of approximately 50 minutes and a cassette player with headphones. They were asked to listen to the recorded music daily in the evening just before going to the bed with a minimum of ambient noise.

Primary Outcome Measures

Name	Time	Method
Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)	Day 2 or 3 of life	Outcome measures consisted of the performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS). The BNBAS is a means of scoring interactive behaviour for term and stable preterm infants. The scale consists of 27 behavioural items, each scored on a 9-point scale, and 20 elicited responses, each scored on a 3-point scale. In most cases, the infant's score is based on the best performance, not an average performance.

Trial Locations

Locations (1)

NSCB Medical College; 🇮🇳 Jabalpur, MP, India