The Impact of Receptive Music Therapy in the ICU

NCT ID: NCT03931733

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2020-03-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Music Therapy Intervention

Receiving one thirty minute music therapy intervention.

Group Type: ACTIVE_COMPARATOR

Music Therapy

Intervention Type: OTHER

Single thirty minute receptive music therapy intervention.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

Single thirty minute receptive music therapy intervention.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inova Loudoun Hospital

Leesburg, Virginia, United States

Countries

United States

Other Identifiers

18-3129

Identifier Type: -

Identifier Source: org_study_id