Music Therapy: An Adjunct To Gastroschisis Infants' Care

Gastroschisis Clinical Trial

— MAGIC  

Official title:

The Effect of Music Therapy On Infants Born With Gastroschisis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01469208
• Other study ID #: 1110096A
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2011
• Last updated: July 31, 2013
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2013
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: Catherine T Worwa, LRT, BS, CCRP
• Phone: 612-813-6864
• Email: cathy.worwa[@]childrensmn.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

1. Diagnosis of Gastroschisis

2. Patient is stable enough to receive music therapy as determined by Neonatologist

3. Patient has passed their newborn hearing screen

Exclusion Criteria:

1. Neonatologist feels patient/family would not be an acceptable research candidate.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroschisis

Locations

Country	Name	City	State
United States	Childrens Hospitals and Clinics of MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Music Therapy will produce stable physiologic, states as well as, positive behavior states	Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions	3 years	No