StressNCT00224211
Music's Effects on Premature Babies.
An observational study of Stress and Sleep, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This project is being done in order to determine if the music of Mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (NICU). The primary effect to be anticipated will be a reduction in heart rate from baseline, decreased motor activity from baseline, as well as an increase… Read more about this study
- Who is it for?
- Ages 1 week to 3 monthsHealthy volunteers can take part
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2007
- Phase
- Observational
- 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 1 week to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature infants
Who may be able to join
- All infants born at 28 weeks gestation or who are at least 28 weeks corrected age are eligible to participate. Only those in isolettes (incubators) will be included. Once a baby has been transitioned to a bassinet or crib, the baby will be pulled from the study. In order to be included, these infants must be in stable condition (without serious active medical issues) as decided by their doctor and must be breathing without the use of a ventilator.
Who cannot join
- Exclusion criteria will include a history of intraventricular hemorrhage involving the white matter (as diagnosed by head ultrasound), as well as those infants born with severe congenital deformities.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital Weill Cornell
New York, New York, 10021
About this study
Official title: Effects of Homophonic Sounds on Preterm Infants
This project is being done in order to determine if the music of Mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (NICU). The primary effect to be anticipated will be a reduction in heart rate from baseline, decreased motor activity from baseline, as well as an increase of time in which the babies are in quiet sleep states while the music is being played.
Upon admission, all infants in the NICU are placed on monitors that continuously track their heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected from the monitors already in use. Total time of observation will be approximately 3 hours. In addition, a monitoring device called an Actiwatch will also be used. This device looks similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of each infant using a foam and velcro strap. This device continuously monitors the baby's movements allowing us to determine if there is a change in the baby's activity level while the music is being played. It will record the baby's activity prior to the start of the music and will continue until 30 minutes after the music has stopped.
The music of Mozart will be played using a small speaker in the baby's isolette. The volume of the music will be set at 10 decibels over background noise, which on previous measurement has been found to be approximately 55 decibels (about the same as a running refrigerator or as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in the crib will be continuously monitored throughout the hour. As a final recording device, we will also intermittently be using video to capture the reactions of these infants to the music. The study will be done once a week per infant on the same day and at the same time every week
- Being tested
- Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
| Study group | Role | What they receive |
|---|---|---|
| I | Stable premature infants Receives: Behavioral: Music |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2007
- Study completionJun 2007
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 StressStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Michelle M Meza, MD, Principal investigator, New York Presbyterian Hospital Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224211
- Sponsor's protocol ID
- 0506007948
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dobson R. Doctors will test whether Mozart can reduce stress in babies. BMJ. 2006 Mar 25;332(7543):688. doi: 10.1136/bmj.332.7543.688-a. No abstract available.
PubMed 16565122
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Homophonic Sounds on Preterm Infants
- ClinicalTrials.gov ID
- NCT00224211
- Acronym / sponsor ID
- 0506007948
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Sep 2005 (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.
This project is being done in order to determine if the music of Mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (NICU). The primary effect to be anticipated will be a reduction in heart rate from baseline, decreased motor activity from baseline, as well as an increase of time in which the babies are in quiet sleep states while the music is being played.
Upon admission, all infants in the NICU are placed on monitors that continuously track their heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected from the monitors already in use. Total time of observation will be approximately 3 hours. In addition, a monitoring device called an Actiwatch will also be used. This device looks similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of each infant using a foam and velcro strap. This device continuously monitors the baby's movements allowing us to determine if there is a change in the baby's activity level while the music is being played. It will record the baby's activity prior to the start of the music and will continue until 30 minutes after the music has stopped.
The music of Mozart will be played using a small speaker in the baby's isolette. The volume of the music will be set at 10 decibels over background noise, which on previous measurement has been found to be approximately 55 decibels (about the same as a running refrigerator or as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in the crib will be continuously monitored throughout the hour. As a final recording device, we will also intermittently be using video to capture the reactions of these infants to the music. The study will be done once a week per infant on the same day and at the same time every week
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Behavioral: MusicStable premature infants |
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature infants
Key inclusion criteria (1 listed)
- All infants born at 28 weeks gestation or who are at least 28 weeks corrected age are eligible to participate. Only those in isolettes (incubators) will be included. Once a baby has been transitioned to a bassinet or crib, the baby will be pulled from the study. In order to be included, these infants must be in stable condition (without serious active medical issues) as decided by their doctor and must be breathing without the use of a ventilator.
Key exclusion criteria (1 listed)
- Exclusion criteria will include a history of intraventricular hemorrhage involving the white matter (as diagnosed by head ultrasound), as well as those infants born with severe congenital deformities.
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 |
|---|---|---|
| Music | Behavioural | I |
Primary outcome
Not reported in the source record.
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 13 Mar 2008.
- Background: PubMed 16565122Dobson R. Doctors will test whether Mozart can reduce stress in babies. BMJ. 2006 Mar 25;332(7543):688. doi: 10.1136/bmj.332.7543.688-a. No abstract available.
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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.
Michelle M Meza, MD principal investigator
New York Presbyterian Hospital Weill Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Sleep, run by Weill Medical College of Cornell University at 1 site in United States.
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 13 Mar 2008. 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 United States. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00224211, 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 13 Mar 2008.