Back to resultsMusic Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
Primary Purpose
Music Therapy for Pain and Sedation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
provide headphones with music playing
Sounds
Sponsored by
About this trial
This is an interventional supportive care trial for Music Therapy for Pain and Sedation focused on measuring pain, agitation, music
Eligibility 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)
Sites / Locations
- University of California, San Francisco at San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
With Music
Control Arm
Arm Description
This randomized group will receive music
Will not receive music but will receive audio loop of recorded ICU sounds
Outcomes
Primary Outcome Measures
Decreased sedation and pain requirements
Secondary Outcome Measures
ICU length of stay
Full Information
NCT ID
NCT01316536
First Posted
March 14, 2011
Last Updated
April 16, 2015
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01316536
Brief Title
Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
Official Title
Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
inability to recruit participants despite numerous attempts
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Therapy for Pain and Sedation
Keywords
pain, agitation, music
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With Music
Arm Type
Experimental
Arm Description
This randomized group will receive music
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Will not receive music but will receive audio loop of recorded ICU sounds
Intervention Type
Other
Intervention Name(s)
provide headphones with music playing
Intervention Description
Participants will be provided with music through headphones
Intervention Type
Other
Intervention Name(s)
Sounds
Intervention Description
recorded ICU sounds will be provided to participants through headphones
Primary Outcome Measure Information:
Title
Decreased sedation and pain requirements
Time Frame
maximum of 7 days from study entry while still intubated and sedated
Secondary Outcome Measure Information:
Title
ICU length of stay
Time Frame
from admission date to ICU to discharge date from ICU while on study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julin Tang, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dante Yeh, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco at San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
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