Music Therapy: An Adjunct To Gastroschisis Infants' Care (MAGIC)
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|ClinicalTrials.gov Identifier: NCT01469208|
Recruitment Status : Unknown
Verified July 2013 by Ellen Bendel-Stenzel, Children's Hospitals and Clinics of Minnesota.
Recruitment status was: Recruiting
First Posted : November 10, 2011
Last Update Posted : August 2, 2013
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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:
- Pre music therapy behavior state will be assessed using CRIES scale and recorded.
- Five minutes of baseline vital signs will be recorded.
- 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.
- After session behavior state using CRIES scale will be recorded.
- Family/caregiver will be given a questionnaire to fill out.
- 30 min of quiet will start.
- At the end of quiet time, behavior state and vital signs will be recorded for the last time.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Effect of Music Therapy On Infants Born With Gastroschisis|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
- Music Therapy will produce stable physiologic, states as well as, positive behavior states [ Time Frame: 3 years ]Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions
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|Ages Eligible for Study:||1 Week to 6 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Diagnosis of Gastroschisis
- Patient is stable enough to receive music therapy as determined by Neonatologist
- Patient has passed their newborn hearing screen
1. Neonatologist feels patient/family would not be an acceptable research candidate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469208
|Contact: Catherine T Worwa, LRT, BS, CCRPfirstname.lastname@example.org|
|United States, Minnesota|
|Childrens Hospitals and Clinics of MN||Recruiting|
|Minneapolis, Minnesota, United States, 55404|
|Contact: Catherine T Worwa 612-813-6864 email@example.com|
|Principal Investigator: Ellen Bendel-Stenzel, MD|
|Sub-Investigator: Melissa Wenszell, MT-BC, NMT|
|Responsible Party:||Ellen Bendel-Stenzel, Co-Director of NICU research - Minneapolis, Children's Hospitals and Clinics of Minnesota|
|Other Study ID Numbers:||
|First Posted:||November 10, 2011 Key Record Dates|
|Last Update Posted:||August 2, 2013|
|Last Verified:||July 2013|
Post surgical repair
Pathological Conditions, Anatomical