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Clinical Trials/NCT03931733
NCT03931733
Completed
Not Applicable

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

Inova Health Care Services1 site in 1 country118 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Inova Health Care Services
Enrollment
118
Locations
1
Primary Endpoint
Change in respiratory rate
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
March 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Prisoners
  • Brain Dead
  • Unstable bradycardia or hypotension
  • Patients who have been referred to music therapy with a goal of stimulation.

Outcomes

Primary Outcomes

Change in respiratory rate

Time Frame: 30 minutes

Physiologic Intervention

Change in Oxygenation

Time Frame: 30 minutes

Physiologic Intervention

Change in heart rate

Time Frame: 30 minutes

Physiologic Intervention

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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