Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care

Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility trial that will explore the feasibility and acceptability of a music therapy intervention to decrease stress in the PICU among families of children receiving invasive or noninvasive mechanical ventilation.

Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music therapy intervention in the PICU among children receiving invasive or non-invasive mechanical ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music therapy intervention will be feasible, as determined by recruitment, retention, protocol adherence, and data collection rates, and will be acceptable to participants and to PICU staff.

Sample: This study will recruit 20 families that include children aged 2 months - 17 years old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families, the investigators will specifically recruit 10 families whose child is admitted for a hypoxic brain injury. Eligible children are receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support settings. One primary caregiver will be enrolled along with the child admitted into the ICU.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Hypoxia, Brain
• Intervention / Treatment: Other: Music therapy

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent/caregiver aged 18 years or older.
• Children aged 2 months - 17 years admitted to the PICU with an expected length of stay greater than 72 hours
• Child is receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support setting

Exclusion Criteria:

• The legal guardian is unclear,
• Caregiver does not read, write, and speak English
• Child is not expected to survive that PICU stay or has care limitations in place
• Child has deafness in both ears, in foster care or justice system, or experiences musicogenic epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music therapy; Music listening intervention provided by a board certified music therapist.	Other: Music therapy; Patient preferred song will be provided in a sedative manor (e.g., 60-80 beats per minute) using live music (singing with guitar accompaniment) by a board certified music therapist.; Other Names: Music listening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of participant recruitment	Feasibility of participant recruitment will be determined via recruitment rate	Throughout study completion, anticipated 1 year
Feasibility of participant retention	Feasibility of participant retention will be determined via retention	Post-intervention completion, anticipated 2 weeks
Feasibility of protocol	Feasibility of protocol will be determined via percentage of sessions that adhere to protocol	Throughout study completion, anticipated 1 year
Feasibility of data collection	Feasibility of data collection will be determined via percentage of participants with complete data capture	Throughout study completion, anticipated 1 year
Acceptability of intervention among participants	Acceptability will be assessed via interviews with participants (caregivers and children 8 years and older) to ascertain intervention benefits, barriers, and potential optimizations.	Post-intervention, anticipated 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Change in child participant heart rate during intervention	Throughout intervention completion, anticipated 2 weeks
Change in oxygen saturation	Change in child participant oxygen saturation during intervention	Throughout intervention completion, anticipated 2 weeks
Change in blood pressure	Change in child participant blood pressure during intervention	Throughout intervention completion, anticipated 2 weeks
Change in saliva cortisol	Change in child and caregiver participant saliva cortisol levels pre-post intervention	Throughout intervention completion, anticipated 2 weeks
Change in saliva inflammatory biomarkers	Change in child participant saliva inflammatory biomarker levels pre-post intervention	Throughout intervention completion, anticipated 2 weeks
Visual Analog Scale - Anxiety	Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.	Throughout intervention completion, anticipated 2 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Jessica M Jarvis, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
• Liu MH, Zhu LH, Peng JX, Zhang XP, Xiao ZH, Liu QJ, Qiu J, Latour JM. Effect of Personalized Music Intervention in Mechanically Ventilated Children in the PICU: A Pilot Study. Pediatr Crit Care Med. 2020 Jan;21(1):e8-e14. doi: 10.1097/PCC.0000000000002159.
• Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Signs and Symptoms, Respiratory; Critical Illness; Hypoxia; Hypoxia, Brain
• Other Study ID Numbers: STUDY19100263

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