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Completed

NCT Number: NCT04280744

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.

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Key information

Age range

2 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

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

Primary outcomes

  1. Feasibility of participant recruitment

    Time frame: Throughout study completion, anticipated 1 year

    Feasibility of participant recruitment will be determined via recruitment rate

  2. Feasibility of participant retention

    Time frame: Post-intervention completion, anticipated 2 weeks

    Feasibility of participant retention will be determined via retention

  3. 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

  4. 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

  5. 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.

Secondary outcomes

  1. Change in heart rate

    Time frame: Throughout intervention completion, anticipated 2 weeks

    Change in child participant heart rate during intervention

  2. Change in oxygen saturation

    Time frame: Throughout intervention completion, anticipated 2 weeks

    Change in child participant oxygen saturation during intervention

  3. Change in blood pressure

    Time frame: Throughout intervention completion, anticipated 2 weeks

    Change in child participant blood pressure during intervention

  4. Change in saliva cortisol

    Time frame: Throughout intervention completion, anticipated 2 weeks

    Change in child and caregiver participant saliva cortisol levels pre-post intervention

  5. Change in saliva inflammatory biomarkers

    Time frame: Throughout intervention completion, anticipated 2 weeks

    Change in child participant saliva inflammatory biomarker levels pre-post intervention

  6. Visual Analog Scale - Anxiety

    Time frame: Throughout intervention completion, anticipated 2 weeks

    Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 21, 2020
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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