Gastroschisis Clinical Trial
Official title:
The Effect of Music Therapy On Infants Born With Gastroschisis
The investigators hope to determine if music therapy will have beneficial effects on
physiologic parameters, behavioral states, and pain scale evaluations in infants with
gastroschisis defects and if music therapy promotes parental/caregiver relaxation and
demonstrates to the parent/caregiver that music is an effective tool to calm and soothe
their infant at risk for chronic gastrointestinal discomfort.
Babies will be enrolled during the perinatal period, with therapy to begin after surgical
repair of the gastroschisis defect and when the neonatologist deems the baby stable enough
for music therapy intervention. Enrolled subjects may receive up to 3 music therapy
sessions/week and these sessions may continue until discharge. There is no follow up after
discharge.
Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:
1. Pre music therapy behavior state will be assessed using CRIES scale and recorded.
2. Five minutes of baseline vital signs will be recorded.
3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and
lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels
will be maintained at 65-75dB. Session will stop if infant shows any signs of
distress/agitation. Vital signs will be collected every 1-4 minutes during music
session.
4. After session behavior state using CRIES scale will be recorded.
5. Family/caregiver will be given a questionnaire to fill out.
6. 30 min of quiet will start.
7. At the end of quiet time, behavior state and vital signs will be recorded for the last
time.
Prior to starting the music therapy session, family/caregivers, if present, will be informed
of study session progression. They will be reminded of appropriate behavioral protocol to
maintain therapeutic environment during session - i.e. minimal taking & touching, cell
phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted
outside pts room on the door.
Behavioral state data and vitals signs collected during sessions will be entered into a
database. Also recorded, will be general information about the baby and its mother, such as,
gestational age, apgar scores, mothers age and race, number of days post surgical repair
etc.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00539292 -
Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
|
Phase 2 | |
| Recruiting |
NCT03724214 -
Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa
|
N/A | |
| Terminated |
NCT00404690 -
Bedside Silo Versus Operative Closure for Gastroschisis
|
N/A | |
| Recruiting |
NCT05704257 -
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
|
N/A | |
| Completed |
NCT03533439 -
Regional Blood Saturation Levels in Gastroschisis
|
||
| Active, not recruiting |
NCT03393832 -
Oral Care in Infants With Gastroschisis
|
||
| Completed |
NCT03666767 -
Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
|
||
| Terminated |
NCT03355326 -
Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis
|
Phase 4 | |
| Completed |
NCT03185637 -
Children's Surgery in Sub-Saharan Africa
|
N/A | |
| Completed |
NCT02575846 -
Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
|
N/A | |
| Terminated |
NCT01094587 -
Sutureless vs Sutured Gastroschisis Closure
|
N/A | |
| Active, not recruiting |
NCT00127946 -
Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
|
Phase 3 | |
| Withdrawn |
NCT04186039 -
Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
|
N/A | |
| Active, not recruiting |
NCT06461325 -
Surgical Management Of Gastroschisis
|
||
| Completed |
NCT03960320 -
Health Related Quality of Life of Patients With Abdominal Wall Defects
|
||
| Terminated |
NCT02098915 -
Metoclopramide Pilot Trial
|
Phase 3 | |
| Completed |
NCT01316510 -
Probiotics in Infants With Gastroschisis
|
N/A | |
| Completed |
NCT04020939 -
The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
|
N/A | |
| Recruiting |
NCT06072976 -
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
|
N/A | |
| Recruiting |
NCT05293353 -
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
|