NCT01316536

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

3.7 years

First QC Date

March 14, 2011

Last Update Submit

April 16, 2015

Conditions

Music Therapy for Pain and Sedation

Keywords

pain, agitation, music

Outcome Measures

Primary Outcomes (1)

  • Decreased sedation and pain requirements

    maximum of 7 days from study entry while still intubated and sedated

Secondary Outcomes (1)

  • ICU length of stay

    from admission date to ICU to discharge date from ICU while on study

Study Arms (2)

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

provide headphones with music playingOTHER

Participants will be provided with music through headphones

With Music
SoundsOTHER

recorded ICU sounds will be provided to participants through headphones

Control Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics

You may not qualify if:

  • hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco at San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

PainPsychomotor Agitation

Interventions

Sound

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Radiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Julin Tang, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Dante Yeh, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 16, 2011

Study Start

April 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(1)