Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
- Conditions
- Critical IllnessHypoxia, Brain
- Interventions
- Other: Music therapy
- Registration Number
- NCT04280744
- Lead Sponsor
- University of Pittsburgh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Music therapy Music therapy Music listening intervention provided by a board certified music therapist.
- Primary Outcome Measures
Name Time Method Feasibility of participant recruitment Throughout study completion, anticipated 1 year Feasibility of participant recruitment will be determined via recruitment rate
Feasibility of participant retention Post-intervention completion, anticipated 2 weeks Feasibility of participant retention will be determined via retention
Feasibility of protocol 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 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 Throughout study completion, anticipated 1 year Feasibility of data collection will be determined via percentage of participants with complete data capture
- Secondary Outcome Measures
Name Time Method Change in blood pressure Throughout intervention completion, anticipated 2 weeks Change in child participant blood pressure during intervention
Change in heart rate Throughout intervention completion, anticipated 2 weeks Change in child participant heart rate during intervention
Change in oxygen saturation Throughout intervention completion, anticipated 2 weeks Change in child participant oxygen saturation during intervention
Visual Analog Scale - Anxiety Throughout intervention completion, anticipated 2 weeks Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.
Change in saliva cortisol Throughout intervention completion, anticipated 2 weeks Change in child and caregiver participant saliva cortisol levels pre-post intervention
Change in saliva inflammatory biomarkers Throughout intervention completion, anticipated 2 weeks Change in child participant saliva inflammatory biomarker levels pre-post intervention
Trial Locations
- Locations (1)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States