Music Therapy With Intubated and Sedated Pediatric Patients

Not Applicable

Completed

• Conditions: Respiratory Syncytial Virus Infections

• Registration Number: NCT03629145
• Lead Sponsor: Children's Healthcare of Atlanta

Brief Summary

The study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. The experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. Caregivers will take a pre and post survey.

Detailed Description

Data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. Caregivers will take the Parental Belief Scale for Hospitalized Children prior to intervention and 60 minutes poster intervention.

Study Timeline

• Study First Submitted: 2017-11-21
• Study Start: 2018-01-16
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu
• mechanically ventilated
• sedated
• Patients with underlying diagnosis accepted unless listed below
• Patients must have a primary caregiver present

Exclusion Criteria

• Patients who are oscillating
• have a previous diagnosis of severe or profoundly deaf
• have a suspicion of child abuse
• in custody of the state.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart Rate	up to sixty minutes post intervention.	Describe the effect of a live music therapy intervention on HR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Blood Pressure	up to sixty minutes post intervention.	Describe the effect of a live music therapy intervention on BP in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Respiratory Rate	up to sixty minutes post intervention.	Describe the effect of a live music therapy intervention on RR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States