Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Music Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Oishei Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional; Music therapy.	Other: Music Therapy; Subjects will receive one hour of music twice a day for three days.
NO_INTERVENTION: Comparison; No music therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richmond Agitation-Sedation Scale (RASS)	The Richmond Agitation-Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient. The scale measures patient agitation and sedation +4 to -5, with a score of 0 equal to an alert and calm patient, a positive score equal to various levels of aggression, and a negative score equal to various levels of sedation. Patients receive one score for one observed time point. Therefore, a patient will have one score from +4 to -5. For the purpose of this study, a better outcome will be a score that is around 0 or that decreases from a higher positive score to a lower positive score. The investigators hypothesize that music therapy will decrease agitation in patients and decrease their positive RASS score.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bispectral Index (BIS)	The Bispectral Index provides a direct measure of the effects of sedatives on the brain. It is an algorithm developed by Aspect Medical Systems that measures EEG after the administration of anesthetic agents and is measure on a BIS monitor. The BIS monitor reports a single number from 0 to 100 that represents an integrated measure of cerebral electrical activity. This is interpreted into a patient's level of alertness. A score of 100 indicates that the patient is fully awake, while a number less than 40 is suggestive of a deep hypnotic effect. For the purpose of this study, the investigators are using the BIS to measure the level of alertness in a patient. The investigators hypothesize that the administration of music therapy with have a sedative effect on patients, thereby decreasing their BIS number.	3 days

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: David Rothstein, MD, SUNY Buffalo

Publications and helpful links

General Publications

• Kudchadkar SR, Berger J, Patel R, Barnes S, Twose C, Walker T, Mitchell R, Song J, Anton B, Punjabi NM. Non-pharmacological interventions for sleep promotion in hospitalized children. Cochrane Database Syst Rev. 2022 Jun 15;6(6):CD012908. doi: 10.1002/14651858.CD012908.pub2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: critical care; music; music therapy; agitation; PICU
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Critical Illness
• Other Study ID Numbers: STUDY00001771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No