Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour (PEXMUSIC)

NSCB Medical College

Status and phase: Completed; Phase 4

Conditions: Normal Healthy Term Appropriate-for-date Newborn

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01278329

PEXMUSIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 339 patients

Sex: Female

Ages: 19 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

339 participants in 2 patient groups

Music

Experimental group

Description:

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.

Treatment:

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

Control

No Intervention group

Description:

Standard routine ante-natal care.