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OpenTrials
Completed

NCT Number: NCT03931733

The Impact of Receptive Music Therapy in the ICU

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Loudoun Hospital

Leesburg, Virginia, 20176, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

Single thirty minute receptive music therapy intervention.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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