Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour (PEXMUSIC)

This study has been completed.
Sponsor:
Information provided by:
NSCB Medical College
ClinicalTrials.gov Identifier:
NCT01278329
First received: January 14, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Normal Healthy Term Appropriate-for-date Newborn
Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Maternal Ante-natal Music Exposure on Neonatal Behavior Measured Using Brazelton Neonatal Behavioral Scale: A Randomized Open-label Study

Further study details as provided by NSCB Medical College:

Primary Outcome Measures:
  • Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS) [ Time Frame: Day 2 or 3 of life ] [ Designated as safety issue: No ]
    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.


Enrollment: 339
Study Start Date: January 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)
Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.
No Intervention: Control
Standard routine ante-natal care.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278329

Locations
India
NSCB Medical College
Jabalpur, MP, India, 482003
Sponsors and Collaborators
NSCB Medical College
Investigators
Study Director: Maya Chansoria, MD NSCB Medical College
  More Information

No publications provided

Responsible Party: Maya Chansoria, NSCB Medical College, Jabalpur, MP, India
ClinicalTrials.gov Identifier: NCT01278329     History of Changes
Other Study ID Numbers: PEXMUSIC
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Department of Health and Family Welfare, Government of Madhya Pradesh : India

Keywords provided by NSCB Medical College:
Music
Foetal learning
Brazelton Neonatal Behavioral Assessment Scale

ClinicalTrials.gov processed this record on July 22, 2014