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Music Therapy With Intubated and Sedated Pediatric Patients

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Live Music Therapy
Recorded Music Therapy
Sponsored by
Children's Healthcare of Atlanta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu
  • mechanically ventilated
  • sedated
  • Patients with underlying diagnosis accepted unless listed below
  • Patients must have a primary caregiver present

Exclusion Criteria:

  • Patients who are oscillating
  • have a previous diagnosis of severe or profoundly deaf
  • have a suspicion of child abuse
  • in custody of the state.

Sites / Locations

  • Children's Healthcare of Atlanta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Live Music Therapy

Recorded Music

Arm Description

Twenty minutes of live, preferred music played on guitar and voice

Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator

Outcomes

Primary Outcome Measures

Heart Rate
Describe the effect of a live music therapy intervention on HR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Respiratory Rate
Describe the effect of a live music therapy intervention on RR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Blood Pressure
Describe the effect of a live music therapy intervention on BP in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2017
Last Updated
July 25, 2019
Sponsor
Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT03629145
Brief Title
Music Therapy With Intubated and Sedated Pediatric Patients
Official Title
The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Healthcare of Atlanta

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
The study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. The experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. Caregivers will take a pre and post survey.
Detailed Description
Data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. Caregivers will take the Parental Belief Scale for Hospitalized Children prior to intervention and 60 minutes poster intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Music Therapy
Arm Type
Experimental
Arm Description
Twenty minutes of live, preferred music played on guitar and voice
Arm Title
Recorded Music
Arm Type
Placebo Comparator
Arm Description
Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator
Intervention Type
Behavioral
Intervention Name(s)
Live Music Therapy
Intervention Description
Investigator will begin play live guitar and voice music.
Intervention Type
Behavioral
Intervention Name(s)
Recorded Music Therapy
Intervention Description
Investigator will play recorded music.
Primary Outcome Measure Information:
Title
Heart Rate
Description
Describe the effect of a live music therapy intervention on HR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Time Frame
up to sixty minutes post intervention.
Title
Respiratory Rate
Description
Describe the effect of a live music therapy intervention on RR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Time Frame
up to sixty minutes post intervention.
Title
Blood Pressure
Description
Describe the effect of a live music therapy intervention on BP in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.
Time Frame
up to sixty minutes post intervention.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu mechanically ventilated sedated Patients with underlying diagnosis accepted unless listed below Patients must have a primary caregiver present Exclusion Criteria: Patients who are oscillating have a previous diagnosis of severe or profoundly deaf have a suspicion of child abuse in custody of the state.
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20426353
Citation
Austin D. The psychophysiological effects of music therapy in intensive care units. Paediatr Nurs. 2010 Apr;22(3):14-20. doi: 10.7748/paed2010.04.22.3.14.c7637.
Results Reference
background
PubMed Identifier
20492042
Citation
Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010 Apr;19(7-8):978-87. doi: 10.1111/j.1365-2702.2009.02845.x.
Results Reference
result
PubMed Identifier
26227333
Citation
Hetland B, Lindquist R, Chlan LL. The influence of music during mechanical ventilation and weaning from mechanical ventilation: A review. Heart Lung. 2015 Sep-Oct;44(5):416-25. doi: 10.1016/j.hrtlng.2015.06.010. Epub 2015 Jul 27.
Results Reference
result

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Music Therapy With Intubated and Sedated Pediatric Patients

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