NCT03629145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

November 21, 2017

Last Update Submit

July 25, 2019

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (3)

  • 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.

    up to sixty minutes post intervention.

  • 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.

    up to sixty minutes post intervention.

  • 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.

    up to sixty minutes post intervention.

Study Arms (2)

Live Music Therapy

EXPERIMENTAL

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

Behavioral: Live Music Therapy

Recorded Music

PLACEBO COMPARATOR

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

Behavioral: Recorded Music Therapy

Interventions

Live Music TherapyBEHAVIORAL

Investigator will begin play live guitar and voice music.

Live Music Therapy
Recorded Music TherapyBEHAVIORAL

Investigator will play recorded music.

Recorded Music

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Related Publications (3)

  • 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.

    PMID: 20426353BACKGROUND

  • 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.

    PMID: 20492042RESULT

  • 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.

    PMID: 26227333RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Music Therapist, Board-Certified

Study Record Dates

First Submitted

November 21, 2017

First Posted

August 14, 2018

Study Start

January 16, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)