Music's Effects on Premature Babies.
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|ClinicalTrials.gov Identifier: NCT00224211|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 13, 2008
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
|Condition or disease||Intervention/treatment|
|Stress Sleep||Behavioral: Music|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Effects of Homophonic Sounds on Preterm Infants|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
Stable premature infants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224211
|United States, New York|
|New York Presbyterian Hospital Weill Cornell|
|New York, New York, United States, 10021|
|Principal Investigator:||Michelle M Meza, MD||New York Presbyterian Hospital Weill Cornell|