Music Therapy: An Adjunct To Gastroschisis Infants' Care

NCT01469208 | Unknown

• 1 other identifier: 1110096A
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Pre music therapy behavior state will be assessed using CRIES scale and recorded.
2. 2.Five minutes of baseline vital signs will be recorded.
3. 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. 4.After session behavior state using CRIES scale will be recorded.
5. 5.Family/caregiver will be given a questionnaire to fill out.
6. 6.30 min of quiet will start.
7. 7.At the end of quiet time, behavior state and vital signs will be recorded for the last time.

Conditions

Gastroschisis

Keywords

Gastroschisis; NICU inpatients; Post surgical repair; Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Week - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

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.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Childrens Hospitals and Clinics of MN

Minneapolis, Minnesota, 55404, United States

RECRUITING

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Catherine T Worwa, LRT, BS, CCRP

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of NICU research - Minneapolis

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 2, 2013

Record last verified: 2013-07

Locations

US (1)