An interventional study of Music therapy in Critical Illness and Hypoxia, Brain, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 2 Months to 17 Years. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive 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.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Compared within Hypoxia, Brain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Music listening intervention provided by a board certified music therapist.
Other: Music 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.
Also known as: Music listening
Feasibility of participant recruitment
Feasibility of participant recruitment will be determined via recruitment rate
Time frame: Throughout study completion, anticipated 1 year
Feasibility of participant retention
Feasibility of participant retention will be determined via retention
Time frame: Post-intervention completion, anticipated 2 weeks
Feasibility of protocol
Feasibility of protocol will be determined via percentage of sessions that adhere to protocol
Time frame: 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
Time frame: 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.
Time frame: Post-intervention, anticipated 2 weeks
Change in heart rate
Change in child participant heart rate during intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in oxygen saturation
Change in child participant oxygen saturation during intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in blood pressure
Change in child participant blood pressure during intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in saliva cortisol
Change in child and caregiver participant saliva cortisol levels pre-post intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in saliva inflammatory biomarkers
Change in child participant saliva inflammatory biomarker levels pre-post intervention
Time frame: 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.
Time frame: Throughout intervention completion, anticipated 2 weeks
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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