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Clinical Trials/NCT03453814
NCT03453814
Completed
Not Applicable

Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

State University of New York at Buffalo1 site in 1 country26 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
State University of New York at Buffalo
Enrollment
26
Locations
1
Primary Endpoint
Richmond Agitation-Sedation Scale (RASS)
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
March 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Rothstein

Associate Professor of Surgery

State University of New York at Buffalo

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Bispectral Index (BIS)(3 days)

Study Sites (1)

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