Music Therapy: An Adjunct To Gastroschisis Infants' Care (MAGIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Ellen Bendel-Stenzel, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01469208
First received: November 8, 2011
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.

Condition
Gastroschisis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Music Therapy On Infants Born With Gastroschisis

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Music Therapy will produce stable physiologic, states as well as, positive behavior states [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

30 infants born with gastroschisis will be enrolled over a 2yr period. All babies will be newborns admitted to the NICU. The babies enrolled will be both male and female and diverse in race and ethnicity.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469208

Contacts
Contact: Catherine T Worwa, LRT, BS, CCRP 612-813-6864 cathy.worwa@childrensmn.org

Locations
United States, Minnesota
Childrens Hospitals and Clinics of MN Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Catherine T Worwa    612-813-6864    cathy.worwa@childrensmn.org   
Principal Investigator: Ellen Bendel-Stenzel, MD         
Sub-Investigator: Melissa Wenszell, MT-BC, NMT         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Ellen Bendel-Stenzel, Co-Director of NICU research - Minneapolis, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01469208     History of Changes
Other Study ID Numbers: 1110096A
Study First Received: November 8, 2011
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Gastroschisis
NICU inpatients
Post surgical repair
Music Therapy

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014