Music Therapy for Pain and SedationNCT01316536
Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
A study testing provide headphones with music playing and Sounds in people with Music Therapy for Pain and Sedation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The study is designed to analyze the use of music therapy to decrease pain and agitation in intubated ICU patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Music Therapy for Pain and Sedation
- What is being tested?
- provide headphones with music playing and Sounds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics
Who cannot join
- hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco at San Francisco General Hospital
San Francisco, California, 94110
About this study
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).
- Conditions
- Music Therapy for Pain and Sedation
- Being tested
- provide headphones with music playing, Sounds
- Keywords
- pain, agitation, music
- Medical subject headings
- Pain, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
provide headphones with music playingOther
Participants will be provided with music through headphones
SoundsOther
recorded ICU sounds will be provided to participants through headphones
| Study group | Role | What they receive |
|---|---|---|
| With Music | Experimental | This randomized group will receive music Receives: Other: provide headphones with music playing |
| Control Arm | Placebo comparator | Will not receive music but will receive audio loop of recorded ICU sounds Receives: Other: Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased sedation and pain requirements
Measured: maximum of 7 days from study entry while still intubated and sedated
Secondary outcomes (1)
ICU length of stay
Measured: from admission date to ICU to discharge date from ICU while on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: inability to recruit participants despite numerous attempts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music Therapy for Pain and SedationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julin Tang, MD, Principal investigator, University of California, San FranciscoDante Yeh, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316536
- Sponsor's protocol ID
- H9025-35126-01
- Other IDs
- 10-04501
- Status last verified
- Apr 2015
- First submitted
- 14 Mar 2011
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
- ClinicalTrials.gov ID
- NCT01316536
- Acronym / sponsor ID
- H9025-35126-01
- Conditions
- Music Therapy for Pain and Sedation
- Keywords
- pain, agitation, music
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to recruit participants despite numerous attempts
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Music | Experimental | Other: provide headphones with music playingThis randomized group will receive music |
| Control Arm | Placebo comparator | Other: SoundsWill not receive music but will receive audio loop of recorded ICU sounds |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics
Key exclusion criteria (1 listed)
- hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| provide headphones with music playingParticipants will be provided with music through headphones | Other | With Music |
| Soundsrecorded ICU sounds will be provided to participants through headphones | Other | Control Arm |
Primary outcome
Decreased sedation and pain requirements
Time frame: maximum of 7 days from study entry while still intubated and sedated
1 secondary outcome
ICU length of stay
Time frame: from admission date to ICU to discharge date from ICU while on study
Results and safety
The study was stopped early (reason given: inability to recruit participants despite numerous attempts). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julin Tang, MD principal investigator
University of California, San Francisco
Dante Yeh, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing provide headphones with music playing and Sounds in people with Music Therapy for Pain and Sedation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inability to recruit participants despite numerous attempts). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased sedation and pain requirements (time frame: maximum of 7 days from study entry while still intubated and sedated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.