The Impact of Receptive Music Therapy in the ICU

Critical Illness Clinical Trial

Official title:

The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931733
• Other study ID #: 18-3129
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2021
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 31, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Music Therapy
Single thirty minute receptive music therapy intervention.

Locations

Country	Name	City	State
United States	Inova Loudoun Hospital	Leesburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate	Physiologic Intervention	30 minutes
Primary	Change in respiratory rate	Physiologic Intervention	30 minutes
Primary	Change in Oxygenation	Physiologic Intervention	30 minutes
Secondary	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.	Pain	30 minutes
Secondary	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	Agitation	30 minutes