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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness, Hypoxia, Brain

Intervention / Treatment
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* Other: Music therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy<br>Music listening intervention provided by a board certified music therapist. | Other: Music therapy<br>* 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.<br>* Other names: Music listening;|

What is the study measuring?
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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 |