Music Therapy: An Adjunct To Gastroschisis Infants' Care
Status unconfirmed
Conditions studied: Gastroschisis
In brief
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.
Key facts
- Study ID
- NCT01469208
- Run by
- Children's Hospitals and Clinics of Minnesota
- People needed
- 30
- Starts
- 2011-10-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2013-08-02
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Gastroschisis
- Patient is stable enough to receive music therapy as determined by Neonatologist
- Patient has passed their newborn hearing screen
You may not qualify if…
- Neonatologist feels patient/family would not be an acceptable research candidate.
Where it is running
- Childrens Hospitals and Clinics of MN — Minneapolis, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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