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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04280744
Enrollment
38
Registered
2020-02-21
Start date
2020-06-29
Completion date
2022-02-01
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hypoxia, Brain

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.

Interventions

OTHERMusic 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.

Sponsors

University of Pittsburgh Medical Center
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Single-arm feasibility trial

Eligibility

Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of participant recruitmentThroughout study completion, anticipated 1 yearFeasibility of participant recruitment will be determined via recruitment rate
Feasibility of participant retentionPost-intervention completion, anticipated 2 weeksFeasibility of participant retention will be determined via retention
Feasibility of protocolThroughout study completion, anticipated 1 yearFeasibility of protocol will be determined via percentage of sessions that adhere to protocol
Feasibility of data collectionThroughout study completion, anticipated 1 yearFeasibility of data collection will be determined via percentage of participants with complete data capture
Acceptability of intervention among participantsPost-intervention, anticipated 2 weeksAcceptability will be assessed via interviews with participants (caregivers and children 8 years and older) to ascertain intervention benefits, barriers, and potential optimizations.

Secondary

MeasureTime frameDescription
Change in heart rateThroughout intervention completion, anticipated 2 weeksChange in child participant heart rate during intervention
Visual Analog Scale - AnxietyThroughout intervention completion, anticipated 2 weeksChange in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.
Change in oxygen saturationThroughout intervention completion, anticipated 2 weeksChange in child participant oxygen saturation during intervention
Change in blood pressureThroughout intervention completion, anticipated 2 weeksChange in child participant blood pressure during intervention
Change in saliva cortisolThroughout intervention completion, anticipated 2 weeksChange in child and caregiver participant saliva cortisol levels pre-post intervention
Change in saliva inflammatory biomarkersThroughout intervention completion, anticipated 2 weeksChange in child participant saliva inflammatory biomarker levels pre-post intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026