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Clinical Trials/NCT01316536
NCT01316536TerminatedNot Applicable

Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients

University of California, San Francisco2 sites in 1 country5 target enrollmentStarted: April 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
2
Primary Endpoint
Decreased sedation and pain requirements

Study Overview

Brief Summary

The study is designed to analyze the use of music therapy to decrease pain and agitation in intubated ICU patients.

Detailed Description

This is a randomized, prospective single-blinded placebo-controlled study of consecutive intubated ICU patients requiring anxiolytics and analgesic medications. Patients will be randomized into two groups: one group will receive music (MUSIC), whereas the other group (CONTROL) will wear headphones, but hear an audio loop of recorded ICU sounds (vent alarms, ambient noise, talking, etc). The two groups will then be analyzed for sedation and analgesia requirements; Ramsay sedation score, ICP in brain injured patients, ventilator days, ICU length of stay, hospital length of stay, mean arterial blood pressure (MAP).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics

Exclusion Criteria

  • hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)

Outcomes

Primary Outcomes

Decreased sedation and pain requirements

Time Frame: maximum of 7 days from study entry while still intubated and sedated

Secondary Outcomes

  • ICU length of stay(from admission date to ICU to discharge date from ICU while on study)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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