Music Therapy With Intubated and Sedated Pediatric Patients

Overview

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.

Full Title of Study: “The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2019

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.

Interventions

  • Behavioral: Live Music Therapy
    • Investigator will begin play live guitar and voice music.
  • Behavioral: Recorded Music Therapy
    • Investigator will play recorded music.

Arms, Groups and Cohorts

  • Experimental: Live Music Therapy
    • Twenty minutes of live, preferred music played on guitar and voice
  • Placebo Comparator: Recorded Music
    • Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 2 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Healthcare of Atlanta
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hannah Ivey, Music Therapist, Board-Certified – Children’s Healthcare of Atlanta

References

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.

Citations Reporting on Results

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.

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.

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