Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591533
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation However extubation can cause stress pain anxiety or discomfort in the patients which results in an increased likelihood of reintubation Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking
The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia
This study is a Randomized clinical trial RCT with two parallel arms The intervention group IG will receive standard care during the extubation process music therapy and the control group CG will receive standard care only The primary outcome measure is heart rate HR measured every minute for 5 minutes before extubation during extubation and up to 10 minutes after extubation Secondary measures are oxygen saturation respiratory rate blood pressure duration of the procedure number of reintubations and heart rate variability
The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia
This study is a Randomized clinical trial RCT with two parallel arms The intervention group IG will receive standard care during the extubation process music therapy and the control group CG will receive standard care only The primary outcome measure is heart rate HR measured every minute for 5 minutes before extubation during extubation and up to 10 minutes after extubation Secondary measures are oxygen saturation respiratory rate blood pressure duration of the procedure number of reintubations and heart rate variability
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