Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408064
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-04-26
Brief Title:
The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate
Sponsor:
Claudia Aristizábal
Organization:
Sanitas University
Study Overview
Official Title:
The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The admission of a newborn to the neonatal intensive care unit NICU represents a potentially harmful sound environment coupled with multiple stressful events However a strategy such as music therapy delivered by a trained music therapist appears to be a non-invasive safe and cost-effective alternative that assists newborns in their physiological self-regulation with a beneficial effect on stabilizing neonatal vital signs so it can be used as a complementary strategy to medical management The aim of this study is to determine the effect of live and pre-recorded music therapy on vital sign variables in newborns older than 32 weeks hospitalized in the neonatal intensive care unit of a high-complexity health institution in Colombia
Detailed Description:
A parallel controlled randomized clinical trial will be conducted
Study Population Newborns older than 32 weeks gestational age at birth hospitalized in the Neonatal Intensive Care Unit of a high-complexity health institution who meet the inclusion criteria
Outcomes Heart rate will be primary outcome Respiratory rate and oxygen saturation will be secondary outcomes The patient monitor will be utilized to measure the heart rate respiratory rate and oxygen saturation
Standardization of measurements
First the trademarks of the medical equipment manufacturers of each of the tools that will be used vital sign monitor and pulse oximeter will be verified to ensure that they correspond to the same commercial brand Since different brands may exhibit variability in standard calibration measurements within the critical range it is important to verify that the tools are of the same brand Secondly it will be verified that each medical tool used has been calibrated within the previous six months with the date of the last calibration recorded so that the device can be used during the study Subsequently the professional in charge of the music company will verify that the guitar to be used during the live music is in tune and suitable for use A decibel regulator will be employed during the implementation of both pre-recorded and live music adjusting the volume of the emitted sound This will ensure that the decibels emitted by each research subject remain within the permitted range of 70 decibel dB Vital variables will be recorded at minute 0 from minute 0 to minute 10 continuously and at 30 minutes after the intervention
Study Population Newborns older than 32 weeks gestational age at birth hospitalized in the Neonatal Intensive Care Unit of a high-complexity health institution who meet the inclusion criteria
Outcomes Heart rate will be primary outcome Respiratory rate and oxygen saturation will be secondary outcomes The patient monitor will be utilized to measure the heart rate respiratory rate and oxygen saturation
Standardization of measurements
First the trademarks of the medical equipment manufacturers of each of the tools that will be used vital sign monitor and pulse oximeter will be verified to ensure that they correspond to the same commercial brand Since different brands may exhibit variability in standard calibration measurements within the critical range it is important to verify that the tools are of the same brand Secondly it will be verified that each medical tool used has been calibrated within the previous six months with the date of the last calibration recorded so that the device can be used during the study Subsequently the professional in charge of the music company will verify that the guitar to be used during the live music is in tune and suitable for use A decibel regulator will be employed during the implementation of both pre-recorded and live music adjusting the volume of the emitted sound This will ensure that the decibels emitted by each research subject remain within the permitted range of 70 decibel dB Vital variables will be recorded at minute 0 from minute 0 to minute 10 continuously and at 30 minutes after the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None