Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-03-01

Brief Summary

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The objective of this study is to administer music therapy to patients in the pediatric intensive care unit (PICU) in order to observe how music affects patient agitation, vital signs, and overall recovery in the unit.

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Detailed Description

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This study is a prospective randomized controlled study to observe patients who have been admitted to the PICU with an altered state of agitation according to the Richmond Agitation Sedation Scale (RASS). These patients will be administered music therapy during a controlled setting in the day to observe whether the introduction of music therapy helps reduce the patient's level of agitation, improving their vital signs and overall recovery in the unit. Once patients are enrolled and have signed consents, patients will receive a headset with music or dead air. Therapy times will be selected so that there are minimal disruptions. Total time will be 2 hours daily, once in the morning and once in the evening. The treatments for session 1 and session 2 of the day will be the same (i.e. Music/ Music, No music/No Music).

The investigators hypothesize that applying music therapy in the PICU will decrease agitation, length of stay, and narcotic administration, and normalize heart rate, respiratory rate, and blood pressure.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Interventional

Music therapy.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type OTHER

Subjects will receive one hour of music twice a day for three days.

Comparison

No music therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Therapy

Subjects will receive one hour of music twice a day for three days.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* PICU patient at Oishei Children's Hospital of Buffalo
* \>4 years of age, \<18 years of age
* Patients with RASS of +1

Exclusion Criteria

* Documented underlying psychological disorders
* Diagnosed with sever developmental delay
* Prior narcotic dependence
* Underlying medical conditions affecting heart rate, blood pressure, or neuromuscular system
* Chemically paralyzed patients
* Anyone with an aneurysm
* Patients who are deaf in both ears
* Ear bone fractures or other middle/inner ear trauma or major ear avulsion as determined by physician
* Hemodynamically unstable patients
* Patients facing imminent death

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No