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TerminatedNCT01316536Updated Apr 17, 2015

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

An interventional study of provide headphones with music playing and Sounds in Music Therapy for Pain and Sedation, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-17.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care

Why this study was terminated
inability to recruit participants despite numerous attempts
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the 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).

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Conditions studied

  • Music Therapy for Pain and Sedation

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Keywords

  • pain, agitation, music
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 5 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Care provider)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    With Music

    This randomized group will receive music

    Other: provide headphones with music playing

  • Placebo comparator
    Control Arm

    Will not receive music but will receive audio loop of recorded ICU sounds

    Other: Sounds

Interventions

  • Otherprovide headphones with music playing

    Participants will be provided with music through headphones

  • OtherSounds

    recorded ICU sounds will be provided to participants through headphones

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What researchers measure

Primary outcomes

  1. Decreased sedation and pain requirements

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

Secondary outcomes

  1. ICU length of stay

    Time frame: from admission date to ICU to discharge date from ICU while on study

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Study locations

1 site
  • University of California, San Francisco at San Francisco General Hospital
    San Francisco, California 94110, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01316536
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Mar 16, 2011
Start date
Apr 2010
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Apr 17, 2015

Study contacts

Julin Tang, MD
principal investigator · University of California, San Francisco
Dante Yeh, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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