The Impact of Receptive Music Therapy in the ICU

NCT03931733 | Completed

• 1 other identifier: 18-3129
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in heart rate

  Physiologic Intervention

  30 minutes

• Change in respiratory rate

  Physiologic Intervention

  30 minutes

• Change in Oxygenation

  Physiologic Intervention

  30 minutes

Secondary Outcomes (2)

• 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 minutes

• 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

  30 minutes

Study Arms (2)

Music Therapy Intervention

ACTIVE COMPARATOR

Receiving one thirty minute music therapy intervention.

Other: Music Therapy

Usual Care

NO INTERVENTION

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

Interventions

Music Therapy OTHER

Single thirty minute receptive music therapy intervention.

Music Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or greater
• On a Mechanical Ventilator

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Loudoun Hospital

Leesburg, Virginia, 20176, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are assigned to either the intervention or control group based on flipping a coin.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: April 30, 2019
• Study Start: November 26, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 31, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)