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Clinical Trials/NCT03629145
NCT03629145CompletedNot Applicable

The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated

Children's Healthcare of Atlanta1 site in 1 country33 target enrollmentStarted: January 16, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
1
Primary Endpoint
Heart Rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
— to 2 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu
  • •mechanically ventilated
  • •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.

Arms & Interventions

Live Music Therapy

Experimental

Twenty minutes of live, preferred music played on guitar and voice

Intervention: Live Music Therapy (Behavioral)

Recorded Music

Placebo Comparator

Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator

Intervention: Recorded Music Therapy (Behavioral)

Outcomes

Primary Outcomes

Heart Rate

Time Frame: 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.

Respiratory Rate

Time Frame: 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.

Blood Pressure

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hannah Ivey

Music Therapist, Board-Certified

Children's Healthcare of Atlanta

Study Sites (1)

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