Clinical trial NCT04280744: Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
Official title: Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Hypoxia, Brain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2020-02-21
Enrollment: 38
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm feasibility trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of participant recruitment
timeFrame: Throughout study completion, anticipated 1 year
measure: Feasibility of participant retention
timeFrame: Post-intervention completion, anticipated 2 weeks
measure: Feasibility of protocol
timeFrame: Throughout study completion, anticipated 1 year
measure: Feasibility of data collection
timeFrame: Throughout study completion, anticipated 1 year
measure: Acceptability of intervention among participants
timeFrame: Post-intervention, anticipated 2 weeks
Secondary outcomes:
measure: Change in heart rate
timeFrame: Throughout intervention completion, anticipated 2 weeks
measure: Change in oxygen saturation
timeFrame: Throughout intervention completion, anticipated 2 weeks
measure: Change in blood pressure
timeFrame: Throughout intervention completion, anticipated 2 weeks
measure: Change in saliva cortisol
timeFrame: Throughout intervention completion, anticipated 2 weeks
measure: Change in saliva inflammatory biomarkers
timeFrame: Throughout intervention completion, anticipated 2 weeks
measure: Visual Analog Scale - Anxiety
timeFrame: Throughout intervention completion, anticipated 2 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jessica M Jarvis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9.
citation: Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
citation: Liu MH, Zhu LH, Peng JX, Zhang XP, Xiao ZH, Liu QJ, Qiu J, Latour JM. Effect of Personalized Music Intervention in Mechanically Ventilated Children in the PICU: A Pilot Study. Pediatr Crit Care Med. 2020 Jan;21(1):e8-e14. doi: 10.1097/PCC.0000000000002159.