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

Music Therapy for Pain and Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01316536
• Other study ID #: H9025-35126-01
• Secondary ID: 10-04501
• Status: Terminated
• Phase: N/A
• First received: March 14, 2011
• Last updated: April 16, 2015
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Music Therapy for Pain and Sedation

Intervention

Other:
• provide headphones with music playing
Participants will be provided with music through headphones
• Sounds
recorded ICU sounds will be provided to participants through headphones

Locations

Country	Name	City	State
United States	University of California, San Francisco at San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased sedation and pain requirements		maximum of 7 days from study entry while still intubated and sedated	No
Secondary	ICU length of stay		from admission date to ICU to discharge date from ICU while on study	No