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The Impact of Receptive Music Therapy in the ICU

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inova Loudoun Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Music Therapy Intervention

Usual Care

Arm Description

Receiving one thirty minute music therapy intervention.

Receiving usual care for a patient in the ICU during a 30 minute intervention.

Outcomes

Primary Outcome Measures

Change in heart rate
Physiologic Intervention
Change in respiratory rate
Physiologic Intervention
Change in Oxygenation
Physiologic Intervention

Secondary Outcome Measures

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
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

Full Information

First Posted
December 19, 2018
Last Updated
February 8, 2021
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT03931733
Brief Title
The Impact of Receptive Music Therapy in the ICU
Official Title
The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Patients are assigned to either the intervention or control group based on flipping a coin.
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy Intervention
Arm Type
Active Comparator
Arm Description
Receiving one thirty minute music therapy intervention.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Receiving usual care for a patient in the ICU during a 30 minute intervention.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
Single thirty minute receptive music therapy intervention.
Primary Outcome Measure Information:
Title
Change in heart rate
Description
Physiologic Intervention
Time Frame
30 minutes
Title
Change in respiratory rate
Description
Physiologic Intervention
Time Frame
30 minutes
Title
Change in Oxygenation
Description
Physiologic Intervention
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
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.
Description
Pain
Time Frame
30 minutes
Title
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
Description
Agitation
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Pregnant Prisoners Brain Dead Unstable bradycardia or hypotension Patients who have been referred to music therapy with a goal of stimulation.
Facility Information:
Facility Name
Inova Loudoun Hospital
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Receptive Music Therapy in the ICU

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