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

NCT04280744 | Completed

• 1 other identifier: STUDY19100263
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Hypoxia, Brain

Outcome Measures

Primary Outcomes (5)

• Feasibility of participant recruitment

  Feasibility of participant recruitment will be determined via recruitment rate

  Throughout study completion, anticipated 1 year

• Feasibility of participant retention

  Feasibility of participant retention will be determined via retention

  Post-intervention completion, anticipated 2 weeks

• Feasibility of protocol

  Feasibility of protocol will be determined via percentage of sessions that adhere to protocol

  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

  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.

  Post-intervention, anticipated 2 weeks

Secondary Outcomes (6)

• Change in heart rate

  Throughout intervention completion, anticipated 2 weeks

• Change in oxygen saturation

  Throughout intervention completion, anticipated 2 weeks

• Change in blood pressure

  Throughout intervention completion, anticipated 2 weeks

• Change in saliva cortisol

  Throughout intervention completion, anticipated 2 weeks

• Change in saliva inflammatory biomarkers

  Throughout intervention completion, anticipated 2 weeks

Study Arms (1)

Music therapy

EXPERIMENTAL

Music listening intervention provided by a board certified music therapist.

Other: Music therapy

Interventions

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.

Also known as: Music listening

Music therapy

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (3)

• 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.

  PMID: 25490233 BACKGROUND

• 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.

  PMID: 23689789 BACKGROUND

• 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.

  PMID: 31652195 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Hypoxia, Brain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica M Jarvis, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Model Details: Single-arm feasibility trial

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: June 29, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)