Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour

NCT ID: NCT01278329

Last Updated: 2011-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Normal Healthy Term Appropriate-for-date Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

"Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)

Intervention Type OTHER

Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.

Control

Standard routine ante-natal care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)

Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NSCB Medical College

OTHER

Sponsor Role lead

Responsible Party

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NSCB Medical College, Jabalpur, MP, India

Principal Investigators

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Maya Chansoria, MD

Role: STUDY_DIRECTOR

NSCB Medical College

Locations

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NSCB Medical College

Jabalpur, Madhya Pradesh, India

Site Status

Countries

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India

References

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Arya R, Chansoria M, Konanki R, Tiwari DK. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial. Int J Pediatr. 2012;2012:901812. doi: 10.1155/2012/901812. Epub 2012 Feb 14.

Reference Type DERIVED
PMID: 22518187 (View on PubMed)

Other Identifiers

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PEXMUSIC

Identifier Type: -

Identifier Source: org_study_id

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