Music Therapy is Associated With Decreased Pain and Agita... | NCT01316536

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

NCT01316536

Sponsor

University of California, San Francisco

Status

Terminated

Last Update Posted

Apr 17, 2015Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Music Therapy for Pain and Sedation

Interventions

provide headphones with music playing
Sounds

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
10-04501	Other Identifier	UCSF CHR

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inability to recruit participants despite numerous attempts

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 14, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2015

Last Update Posted Date

Apr 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With Music	Experimental	This randomized group will receive music	Other: provide headphones with music playing
Control Arm	Placebo Comparator	Will not receive music but will receive audio loop of recorded ICU sounds	Other: Sounds

Interventions

Name	Type	Description	Arm Group Labels	Other Names
provide headphones with music playing	Other	Participants will be provided with music through headphones	With Music

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decreased sedation and pain requirements		maximum of 7 days from study entry while still intubated and sedated

Secondary Outcomes

Measure	Description	Time Frame
ICU length of stay		from admission date to ICU to discharge date from ICU while on study

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julin Tang, MD	University of California, San Francisco	Principal Investigator
Dante Yeh, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco at San Francisco General Hospital		San Francisco	California	94110	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D011595	Psychomotor Agitation

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D020820	Dyskinesias

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013016	Sound

Ancestor Terms

ID	Term
D011840	Radiation, Nonionizing
D011827	Radiation
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided