Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT03453814
• Recruitment Status: Completed
• First Posted: March 5, 2018
• Last Update Posted: March 30, 2020
• Sponsor: State University of New York at Buffalo
• Information provided by (Responsible Party): David Rothstein, State University of New York at Buffalo

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Critical Illness	Other: Music Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: March 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 3 days ]
   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.

Secondary Outcome Measures :

1. Bispectral Index (BIS) [ Time Frame: 3 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Oishei Children's Hospital

Buffalo, New York, United States, 14203

Sponsors and Collaborators

State University of New York at Buffalo

Investigators

• Principal Investigator: David Rothstein, MD; SUNY Buffalo

More Information

• Responsible Party: David Rothstein, Associate Professor of Surgery, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT03453814
• Other Study ID Numbers: STUDY00001771
• First Posted: March 5, 2018
• Last Update Posted: March 30, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Rothstein, State University of New York at Buffalo:

PICU; critical care; music; music therapy; agitation

Additional relevant MeSH terms:

Psychomotor Agitation; Critical Illness; Disease Attributes; Pathologic Processes; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations