Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224211
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2005-09-20
Brief Title:
Musics Effects on Premature Babies
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Effects of Homophonic Sounds on Preterm Infants
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 babys movements allowing us to determine if there is a change in the babys activity level while the music is being played It will record the babys 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 babys 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
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 babys movements allowing us to determine if there is a change in the babys activity level while the music is being played It will record the babys 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 babys 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None