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Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring PICU, critical care, music, music therapy, agitation

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oishei Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Comparison

Arm Description

Music therapy.

No music therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2018
Last Updated
March 27, 2020
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03453814
Brief Title
Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit
Official Title
Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
PICU, critical care, music, music therapy, agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Music therapy.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
No music therapy.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
Subjects will receive one hour of music twice a day for three days.
Primary Outcome Measure Information:
Title
Richmond Agitation-Sedation Scale (RASS)
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Bispectral Index (BIS)
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rothstein, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oishei Children's Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35703367
Citation
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.
Results Reference
derived

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Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

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