The Impact of Receptive Music Therapy in the ICU

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Other: Music Therapy

• Registration Number: NCT03931733
• Lead Sponsor: Inova Health Care Services

Brief Summary

The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• 18 years of age or greater
• On a Mechanical Ventilator

Exclusion Criteria

• Airborne and Special Contact Isolation
• Non English or Spanish Speaking LARs
• Pregnant
• Prisoners
• Brain Dead
• Unstable bradycardia or hypotension
• Patients who have been referred to music therapy with a goal of stimulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Therapy Intervention	Music Therapy	Receiving one thirty minute music therapy intervention.

Primary Outcome Measures

Name	Time	Method
Change in respiratory rate	30 minutes	Physiologic Intervention
Change in Oxygenation	30 minutes	Physiologic Intervention
Change in heart rate	30 minutes	Physiologic Intervention

Secondary Outcome Measures

Name	Time	Method
Critical Care Pain Observation Tool (CPOT): Range of 0-8 Includes 2 points for: Facial expression, body movements, muscle tension, compliance with the ventilator/vocalization. Intent is decrease in pain level.	30 minutes	Pain
RASS: The Richmond Agitation and Sedation Scale (RASS) 0 (Alert and Calm) -1 -5: Drowsy/Unarousable +1-+4 Agitated/Combative Intent is decrease in agitation level	30 minutes	Agitation

Trial Locations

Locations (1)

Inova Loudoun Hospital; 🇺🇸 Leesburg, Virginia, United States