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The Impact of Receptive Music Therapy in the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03931733
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : March 3, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Music Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Patients are assigned to either the intervention or control group based on flipping a coin.
Primary Purpose: Other
Official Title: The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Active Comparator: Music Therapy Intervention
Receiving one thirty minute music therapy intervention.
Other: Music Therapy
Single thirty minute receptive music therapy intervention.

No Intervention: Usual Care
Receiving usual care for a patient in the ICU during a 30 minute intervention.

Primary Outcome Measures :
  1. Change in heart rate [ Time Frame: 30 minutes ]
    Physiologic Intervention

  2. Change in respiratory rate [ Time Frame: 30 minutes ]
    Physiologic Intervention

  3. Change in Oxygenation [ Time Frame: 30 minutes ]
    Physiologic Intervention

Secondary Outcome Measures :
  1. 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. [ Time Frame: 30 minutes ]

  2. 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 [ Time Frame: 30 minutes ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03931733

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Contact: Amanda J Golino, MSN 703-858-6310

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United States, Virginia
Inova Loudoun Hospital Recruiting
Leesburg, Virginia, United States, 20176
Contact: Amanda J Golino, MSN    703-858-6310   
Principal Investigator: Amanda J Golino, MSN         
Sponsors and Collaborators
Inova Health Care Services
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Responsible Party: Inova Health Care Services Identifier: NCT03931733    
Other Study ID Numbers: 18-3129
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes