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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

January 14, 2011
January 14, 2011
January 2003
December 2005   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Normal Healthy Term Appropriate-for-date Newborn
Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)
Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.
  • 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.
    Intervention: Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)
  • No Intervention: Control
    Standard routine ante-natal care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
339
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Female
19 Years to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01278329
PEXMUSIC
Yes
Maya Chansoria, NSCB Medical College, Jabalpur, MP, India
NSCB Medical College
Not Provided
Study Director: Maya Chansoria, MD NSCB Medical College
NSCB Medical College
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP