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

Not Applicable

Terminated

• Conditions: Music Therapy for Pain and Sedation
• Interventions: Other: Sounds; Other: provide headphones with music playing

• Registration Number: NCT01316536
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-16
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Arm	Sounds	Will not receive music but will receive audio loop of recorded ICU sounds
With Music	provide headphones with music playing	This randomized group will receive music

Primary Outcome Measures

Name	Time	Method
Decreased sedation and pain requirements	maximum of 7 days from study entry while still intubated and sedated

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	from admission date to ICU to discharge date from ICU while on study

Trial Locations

Locations (1)

University of California, San Francisco at San Francisco General Hospital; 🇺🇸 San Francisco, California, United States