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The Impact of Receptive Music Therapy in the ICU

  • Clinicaltrials.gov identifier

    NCT03931733

  • Recruitment Status

    Completed

  • First Posted

    April 30, 2019

  • Last update posted

    February 9, 2021

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.

  • Condition or Disease:Critical Illness
  • Intervention/Treatment: Other: Music Therapy
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 118 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • 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 2018
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020

Arms and interventions

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.

Outcome Measures

  • 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 ]
    Pain
  • 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 ]
    Agitation

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Locations

United States, Virginia
Inova Loudoun Hospital
Leesburg

Sponsors and Collaborators

Inova Health Care Services

More Information

  • Responsible Party: Inova Health Care Services
  • ClinicalTrials.gov Identifier: NCT03931733 History of Changes
  • Other Study ID Numbers: 18-3129
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: February 9, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Critical Illness