Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
Primary Purpose
Critical Illness, Hypoxia, Brain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness
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.
Sites / Locations
- UPMC Children's Hospital of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music therapy
Arm Description
Music listening intervention provided by a board certified music therapist.
Outcomes
Primary Outcome Measures
Feasibility of participant recruitment
Feasibility of participant recruitment will be determined via recruitment rate
Feasibility of participant retention
Feasibility of participant retention will be determined via retention
Feasibility of protocol
Feasibility of protocol will be determined via percentage of sessions that adhere to protocol
Feasibility of data collection
Feasibility of data collection will be determined via percentage of participants with complete data capture
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.
Secondary Outcome Measures
Change in heart rate
Change in child participant heart rate during intervention
Change in oxygen saturation
Change in child participant oxygen saturation during intervention
Change in blood pressure
Change in child participant blood pressure during intervention
Change in saliva cortisol
Change in child and caregiver participant saliva cortisol levels pre-post intervention
Change in saliva inflammatory biomarkers
Change in child participant saliva inflammatory biomarker levels pre-post intervention
Visual Analog Scale - Anxiety
Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.
Full Information
NCT ID
NCT04280744
First Posted
February 19, 2020
Last Updated
February 1, 2022
Sponsor
University of Pittsburgh
Collaborators
University of Pittsburgh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04280744
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
University of Pittsburgh Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Hypoxia, Brain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Music listening intervention provided by a board certified music therapist.
Intervention Type
Other
Intervention Name(s)
Music therapy
Other Intervention Name(s)
Music listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of participant recruitment
Description
Feasibility of participant recruitment will be determined via recruitment rate
Time Frame
Throughout study completion, anticipated 1 year
Title
Feasibility of participant retention
Description
Feasibility of participant retention will be determined via retention
Time Frame
Post-intervention completion, anticipated 2 weeks
Title
Feasibility of protocol
Description
Feasibility of protocol will be determined via percentage of sessions that adhere to protocol
Time Frame
Throughout study completion, anticipated 1 year
Title
Feasibility of data collection
Description
Feasibility of data collection will be determined via percentage of participants with complete data capture
Time Frame
Throughout study completion, anticipated 1 year
Title
Acceptability of intervention among participants
Description
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
Secondary Outcome Measure Information:
Title
Change in heart rate
Description
Change in child participant heart rate during intervention
Time Frame
Throughout intervention completion, anticipated 2 weeks
Title
Change in oxygen saturation
Description
Change in child participant oxygen saturation during intervention
Time Frame
Throughout intervention completion, anticipated 2 weeks
Title
Change in blood pressure
Description
Change in child participant blood pressure during intervention
Time Frame
Throughout intervention completion, anticipated 2 weeks
Title
Change in saliva cortisol
Description
Change in child and caregiver participant saliva cortisol levels pre-post intervention
Time Frame
Throughout intervention completion, anticipated 2 weeks
Title
Change in saliva inflammatory biomarkers
Description
Change in child participant saliva inflammatory biomarker levels pre-post intervention
Time Frame
Throughout intervention completion, anticipated 2 weeks
Title
Visual Analog Scale - Anxiety
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Jarvis, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25490233
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.
Results Reference
background
PubMed Identifier
23689789
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.
Results Reference
background
PubMed Identifier
31652195
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.
Results Reference
background
Learn more about this trial
Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
We'll reach out to this number within 24 hrs