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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01316536
First received: March 14, 2011
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Music Therapy for Pain and Sedation
Other: provide headphones with music playing
Other: Sounds

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Decreased sedation and pain requirements [ Time Frame: maximum of 7 days from study entry while still intubated and sedated ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: from admission date to ICU to discharge date from ICU while on study ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01316536     History of Changes
Other Study ID Numbers: H9025-35126-01, 10-04501
Study First Received: March 14, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014