Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour (PEXMUSIC)

January 14, 2011 updated by: NSCB Medical College

Effect of Maternal Ante-natal Music Exposure on Neonatal Behavior Measured Using Brazelton Neonatal Behavioral Scale: A Randomized Open-label Study

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

339

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • MP
      • Jabalpur, MP, India, 482003
        • NSCB Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 29 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music
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.
Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.
NO_INTERVENTION: Control
Standard routine ante-natal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)
Time Frame: 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.
Day 2 or 3 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Maya Chansoria, MD, NSCB Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (ESTIMATE)

January 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • PEXMUSIC

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