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Clinical Trials/NCT04280744
NCT04280744
Completed
Not Applicable

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

University of Pittsburgh1 site in 1 country38 target enrollmentJune 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
University of Pittsburgh
Enrollment
38
Locations
1
Primary Endpoint
Feasibility of participant recruitment
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2020
End Date
February 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Jarvis

Postdoctoral Scholar

University of Pittsburgh

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Feasibility of participant recruitment

Time Frame: Throughout study completion, anticipated 1 year

Feasibility of participant recruitment will be determined via recruitment rate

Feasibility of participant retention

Time Frame: Post-intervention completion, anticipated 2 weeks

Feasibility of participant retention will be determined via retention

Feasibility of protocol

Time Frame: Throughout study completion, anticipated 1 year

Feasibility of protocol will be determined via percentage of sessions that adhere to protocol

Acceptability of intervention among participants

Time Frame: Post-intervention, anticipated 2 weeks

Acceptability will be assessed via interviews with participants (caregivers and children 8 years and older) to ascertain intervention benefits, barriers, and potential optimizations.

Feasibility of data collection

Time Frame: Throughout study completion, anticipated 1 year

Feasibility of data collection will be determined via percentage of participants with complete data capture

Secondary Outcomes

  • Change in heart rate(Throughout intervention completion, anticipated 2 weeks)
  • Change in blood pressure(Throughout intervention completion, anticipated 2 weeks)
  • Change in oxygen saturation(Throughout intervention completion, anticipated 2 weeks)
  • Visual Analog Scale - Anxiety(Throughout intervention completion, anticipated 2 weeks)
  • Change in saliva cortisol(Throughout intervention completion, anticipated 2 weeks)
  • Change in saliva inflammatory biomarkers(Throughout intervention completion, anticipated 2 weeks)

Study Sites (1)

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