Music Therapy With Intubated and Sedated Pediatric Patients

NCT ID: NCT03629145

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2019-06-01

Brief Summary

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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

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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.

Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Live Music Therapy

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

Group Type EXPERIMENTAL

Live Music Therapy

Intervention Type BEHAVIORAL

Investigator will begin play live guitar and voice music.

Recorded Music

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

Group Type PLACEBO_COMPARATOR

Recorded Music Therapy

Intervention Type BEHAVIORAL

Investigator will play recorded music.

Interventions

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Live Music Therapy

Investigator will begin play live guitar and voice music.

Intervention Type BEHAVIORAL

Recorded Music Therapy

Investigator will play recorded music.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Responsible Party

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Hannah Ivey

Music Therapist, Board-Certified

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20426353 (View on PubMed)

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.

Reference Type RESULT
PMID: 20492042 (View on PubMed)

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.

Reference Type RESULT
PMID: 26227333 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MUSIC02

Identifier Type: -

Identifier Source: org_study_id

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