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

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University of Pittsburgh

Status

Completed

Conditions

Critical Illness
Hypoxia, Brain

Treatments

Other: Music therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04280744
STUDY19100263

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

2 months to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Music therapy
Experimental group
Description:
Music listening intervention provided by a board certified music therapist.
Treatment:
Other: Music therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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