Recruiting

Music Therapy

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT01469208

Conditions

Gastroschisis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Gastroschisis

Study ID

NCT01469208

Start date

Oct, 2011

Status verified date

Jul, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Music Therapy will produce stable physiologic, states as well as, positive behavior states [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Catherine T Worwa, LRT, BS, CCRP

612-813-6864cathy.worwa@childrensmn.org

Locations

Childrens Hospitals and Clinics of MN

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Ellen Bendel-Stenzel, MD

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Aug 2, 2013

Last verified

Jul, 2013

Keywords

  • Gastroschisis
  • NICU inpatients
  • Post surgical repair
  • Music Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2013-08-02.