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

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ClinicalTrials.gov Identifier: NCT01316536
Recruitment Status : Terminated (inability to recruit participants despite numerous attempts)
First Posted : March 16, 2011
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Music Therapy for Pain and Sedation Other: provide headphones with music playing Other: Sounds Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
Study Start Date : April 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: With Music
This randomized group will receive music
Other: provide headphones with music playing
Participants will be provided with music through headphones

Placebo Comparator: Control Arm
Will not receive music but will receive audio loop of recorded ICU sounds
Other: Sounds
recorded ICU sounds will be provided to participants through headphones




Primary Outcome Measures :
  1. Decreased sedation and pain requirements [ Time Frame: maximum of 7 days from study entry while still intubated and sedated ]

Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: from admission date to ICU to discharge date from ICU while on study ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316536


Locations
United States, California
University of California, San Francisco at San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Julin Tang, MD University of California, San Francisco
Principal Investigator: Dante Yeh, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01316536     History of Changes
Other Study ID Numbers: H9025-35126-01
10-04501 ( Other Identifier: UCSF CHR )
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by University of California, San Francisco:
pain, agitation, music

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms