- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278329
Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour (PEXMUSIC)
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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MP
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Jabalpur, MP, India, 482003
- NSCB Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Approximate playing time = 50 minutes.
Mothers advised to listen to it once every day.
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NO_INTERVENTION: Control
Standard routine ante-natal care.
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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
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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.
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Day 2 or 3 of life
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maya Chansoria, MD, NSCB Medical College
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PEXMUSIC
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