Clinical trial NCT01278329: Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour
Official title: Effect of Maternal Ante-natal Music Exposure on Neonatal Behavior Measured Using Brazelton Neonatal Behavioral Scale: A Randomized Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Normal Healthy Term Appropriate-for-date Newborn
Keywords: Music
Foetal learning
Brazelton Neonatal Behavioral Assessment Scale
Lead sponsor: NSCB Medical College
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 339
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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 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

Primary outcomes:
measure: Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)
timeFrame: Day 2 or 3 of life
Secondary outcomes:
Other outcomes:
Locations:
city: Jabalpur
country: India
facility: NSCB Medical College
state: MP
Study officials:
affiliation: NSCB Medical College
name: Maya Chansoria, MD
role: STUDY_DIRECTOR
References:
citation: 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.