Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit

NCT03453814 | Completed

• 1 other identifier: STUDY00001771
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

PICU; critical care; music; music therapy; agitation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days

Secondary Outcomes (1)

• Bispectral Index (BIS)

  3 days

Study Arms (2)

Interventional

EXPERIMENTAL

Music therapy.

Other: Music Therapy

Comparison

NO INTERVENTION

No music therapy.

Interventions

Music Therapy OTHER

Subjects will receive one hour of music twice a day for three days.

Interventional

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• PICU patient at Oishei Children's Hospital of Buffalo
• \>4 years of age, \<18 years of age
• Patients with RASS of +1

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• 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.

  PMID: 35703367 DERIVED

MeSH Terms

Conditions

Critical Illness; Psychomotor Agitation

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Rothstein, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: November 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)