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The Impact of Receptive Music Therapy in the ICU

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931733
Enrollment
118
Registered
2019-04-30
Start date
2018-11-26
Completion date
2020-03-31
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

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.

Interventions

OTHERMusic Therapy

Single thirty minute receptive music therapy intervention.

Sponsors

Inova Health Care Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Masking description

Patients are assigned to either the intervention or control group based on flipping a coin.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in heart rate30 minutesPhysiologic Intervention
Change in respiratory rate30 minutesPhysiologic Intervention
Change in Oxygenation30 minutesPhysiologic Intervention

Secondary

MeasureTime frameDescription
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 minutesPain
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 level30 minutesAgitation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026