Normal Healthy Term Appropriate-for-date NewbornPhase 4PEXMUSICNCT01278329
Maternal Music Exposure During Pregnancy Influences Neonatal Behaviour
A Phase 4 study testing "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India) in people with Normal Healthy Term Appropriate-for-date Newborn, run by NSCB Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 29 years, women only
- Conditions the study is for
- Normal Healthy Term Appropriate-for-date Newborn
- What is being tested?
- "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2003to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Mothers with significant co-existing medical diseases or severe to profound hearing loss were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)
- Keywords
- Music, Foetal learning, Brazelton Neonatal Behavioral Assessment Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)Other
Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | 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. Receives: Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India) |
| Control | No intervention | Standard routine ante-natal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)
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.
Measured: Day 2 or 3 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Healthy Term Appropriate-for-date NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSCB Medical College
- Sponsor type
- University, hospital or other
- Investigators
- Maya Chansoria, MD, Study director, NSCB Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278329
- Sponsor's protocol ID
- PEXMUSIC
- Acronym
- PEXMUSIC
- Status last verified
- Dec 2010
- First submitted
- 14 Jan 2011
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22518187
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Ante-natal Music Exposure on Neonatal Behavior Measured Using Brazelton Neonatal Behavioral Scale: A Randomized Open-label Study
- ClinicalTrials.gov ID
- NCT01278329
- Acronym / sponsor ID
- PEXMUSIC / PEXMUSIC
- Keywords
- Music, Foetal learning, Brazelton Neonatal Behavioral Assessment Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- NSCB Medical CollegeUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)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. |
| Control | No intervention | –Standard routine ante-natal care. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Mothers with significant co-existing medical diseases or severe to profound hearing loss were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India)Approximate playing time = 50 minutes. Mothers advised to listen to it once every day. | Other | Music |
Primary outcome
Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)
Time frame: Day 2 or 3 of life
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
- Derived from this study: PubMed 22518187Arya 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Chansoria, MD study director
NSCB Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "Garbh Sanskar" audio cassette (Times Music Inc., Mumbai, India) in people with Normal Healthy Term Appropriate-for-date Newborn, run by NSCB Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS) (time frame: Day 2 or 3 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.