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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280744
• Other study ID #: STUDY19100263
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Hypoxia
• Hypoxia, Brain

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of participant recruitment	Feasibility of participant recruitment will be determined via recruitment rate	Throughout study completion, anticipated 1 year
Primary	Feasibility of participant retention	Feasibility of participant retention will be determined via retention	Post-intervention completion, anticipated 2 weeks
Primary	Feasibility of protocol	Feasibility of protocol will be determined via percentage of sessions that adhere to protocol	Throughout study completion, anticipated 1 year
Primary	Feasibility of data collection	Feasibility of data collection will be determined via percentage of participants with complete data capture	Throughout study completion, anticipated 1 year
Primary	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.	Post-intervention, anticipated 2 weeks
Secondary	Change in heart rate	Change in child participant heart rate during intervention	Throughout intervention completion, anticipated 2 weeks
Secondary	Change in oxygen saturation	Change in child participant oxygen saturation during intervention	Throughout intervention completion, anticipated 2 weeks
Secondary	Change in blood pressure	Change in child participant blood pressure during intervention	Throughout intervention completion, anticipated 2 weeks
Secondary	Change in saliva cortisol	Change in child and caregiver participant saliva cortisol levels pre-post intervention	Throughout intervention completion, anticipated 2 weeks
Secondary	Change in saliva inflammatory biomarkers	Change in child participant saliva inflammatory biomarker levels pre-post intervention	Throughout intervention completion, anticipated 2 weeks
Secondary	Visual Analog Scale - Anxiety	Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.	Throughout intervention completion, anticipated 2 weeks