Clinical trial NCT03453814: 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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: PICU
critical care
music
music therapy
agitation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: 3 days
Secondary outcomes:
measure: Bispectral Index (BIS)
timeFrame: 3 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Oishei Children's Hospital
state: New York
Study officials:
affiliation: SUNY Buffalo
name: David Rothstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.