Music Therapy With Intubated and Sedated Pediatric Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Behavioral: Live Music Therapy; Behavioral: Recorded Music Therapy

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live Music Therapy; Twenty minutes of live, preferred music played on guitar and voice	Behavioral: Live Music Therapy; Investigator will begin play live guitar and voice music.
Placebo Comparator: Recorded Music; Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator	Behavioral: Recorded Music Therapy; Investigator will play recorded music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	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.	up to sixty minutes post intervention.
Respiratory Rate	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.	up to sixty minutes post intervention.
Blood Pressure	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.	up to sixty minutes post intervention.

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta

Publications and helpful links

General Publications

• Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010 Apr;19(7-8):978-87. doi: 10.1111/j.1365-2702.2009.02845.x.
• Austin D. The psychophysiological effects of music therapy in intensive care units. Paediatr Nurs. 2010 Apr;22(3):14-20. doi: 10.7748/paed2010.04.22.3.14.c7637.
• Hetland B, Lindquist R, Chlan LL. The influence of music during mechanical ventilation and weaning from mechanical ventilation: A review. Heart Lung. 2015 Sep-Oct;44(5):416-25. doi: 10.1016/j.hrtlng.2015.06.010. Epub 2015 Jul 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: MUSIC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No