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Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

Critical Illness

Treatments

Other: Music Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03453814
STUDY00001771

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups

Interventional
Experimental group
Description:
Music therapy.
Treatment:
Other: Music Therapy
Comparison
No Intervention group
Description:
No music therapy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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