Pain ManagementPhase 1MTS1NCT00822497
Efficacy of Music Therapy Protocols for Burn Debridement
A Phase 1 study testing Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) in people with Pain Management, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Music-Based Imagery (MBI) and Music Alternate Engagement (MAE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jul 2010
- Phase
- Phase 1
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is admitted for at least three days (excluding day of admission)
- Patient is at least seven years old
- Patient is able to communicate, i.e. awake and alert
- Patient is oriented
Who cannot join
- Patient admitted for/less than three days
- Patient under seven years of age
- Patient not able to communicate, i.e. sedated and/or intubated
- Patient is not oriented, i.e. active psychosis, hallucinations, delusions, late-stage Alzheimer's or dementia diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Music Therapy Protocols for Decreasing Pain, Anxiety, and Muscle Tension Levels During Burn Debridement: A Prospective Randomized Crossover Trial
The purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns.
Read the detailed description
The study is a prospective, randomized crossover clinical trial conducted on a 14-bed inpatient comprehensive burn care center. The purpose of this study is to investigate the efficacy of Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) for pain and anxiety management for burn patients throughout the debridement process.
- Conditions
- Pain Management
- Being tested
- Music-Based Imagery (MBI), Music Alternate Engagement (MAE)
- Keywords
- music therapy, pain, anxiety, muscle tension
- Medical subject headings
- Agnosia, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-Based Imagery (MBI)Behavioural
Also called Music & Imagery
MBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process.
Music Alternate Engagement (MAE)Behavioural
Also called Distraction Technique
MAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Music-Based Imagery Receives: Behavioral: Music-Based Imagery (MBI) |
| 2 | Experimental | Music Alternate Engagement Receives: Behavioral: Music Alternate Engagement (MAE) |
| Control | No intervention | Debridement under standard care with no music therapy interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Anxiety, Muscle Tension levels
Measured: 7 data points before, during, after debridement
Secondary outcomes (1)
Narcotics & Anxiolytics (dosage)
Measured: Throughout debridement process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startOct 2004
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Music School Settlement, Kulas Foundation
- Investigators
- Xueli Tan, MM, MT-BC, Study chair, The Cleveland Music School SettlementRichard B. Fratianne, MD, FACS, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822497
- Sponsor's protocol ID
- 99-00147
- Acronym
- MTS1
- Status last verified
- Jul 2010
- First submitted
- 13 Jan 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Prensner JD, Yowler CJ, Smith LF, Steele AL, Fratianne RB. Music therapy for assistance with pain and anxiety management in burn treatment. J Burn Care Rehabil. 2001 Jan-Feb;22(1):83-8; discussion 82-3. doi: 10.1097/00004630-200101000-00019.
PubMed 11227691Fratianne RB, Prensner JD, Huston MJ, Super DM, Yowler CJ, Standley JM. The effect of music-based imagery and musical alternate engagement on the burn debridement process. J Burn Care Rehabil. 2001 Jan-Feb;22(1):47-53. doi: 10.1097/00004630-200101000-00010.
PubMed 11227684
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Music Therapy Protocols for Decreasing Pain, Anxiety, and Muscle Tension Levels During Burn Debridement: A Prospective Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT00822497
- Acronym / sponsor ID
- MTS1 / 99-00147
- Conditions
- Pain Management
- Keywords
- music therapy, pain, anxiety, muscle tension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- The Cleveland Music School Settlement, Kulas Foundation
- Study start
- Oct 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Jan 2009 (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 purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns.
Detailed description
The study is a prospective, randomized crossover clinical trial conducted on a 14-bed inpatient comprehensive burn care center. The purpose of this study is to investigate the efficacy of Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) for pain and anxiety management for burn patients throughout the debridement process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Music-Based Imagery (MBI)Music-Based Imagery |
| 2 | Experimental | Behavioral: Music Alternate Engagement (MAE)Music Alternate Engagement |
| Control | No intervention | –Debridement under standard care with no music therapy interventions |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is admitted for at least three days (excluding day of admission)
- Patient is at least seven years old
- Patient is able to communicate, i.e. awake and alert
- Patient is oriented
Key exclusion criteria (4 listed)
- Patient admitted for/less than three days
- Patient under seven years of age
- Patient not able to communicate, i.e. sedated and/or intubated
- Patient is not oriented, i.e. active psychosis, hallucinations, delusions, late-stage Alzheimer's or dementia diagnoses
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 |
|---|---|---|
| Music-Based Imagery (MBI)Also: Music & ImageryMBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process. | Behavioural | 1 |
| Music Alternate Engagement (MAE)Also: Distraction TechniqueMAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process. | Behavioural | 2 |
Primary outcome
Pain, Anxiety, Muscle Tension levels
Time frame: 7 data points before, during, after debridement
1 secondary outcome
Narcotics & Anxiolytics (dosage)
Time frame: Throughout debridement process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
- Background: PubMed 11227691Prensner JD, Yowler CJ, Smith LF, Steele AL, Fratianne RB. Music therapy for assistance with pain and anxiety management in burn treatment. J Burn Care Rehabil. 2001 Jan-Feb;22(1):83-8; discussion 82-3. doi: 10.1097/00004630-200101000-00019.
- Background: PubMed 11227684Fratianne RB, Prensner JD, Huston MJ, Super DM, Yowler CJ, Standley JM. The effect of music-based imagery and musical alternate engagement on the burn debridement process. J Burn Care Rehabil. 2001 Jan-Feb;22(1):47-53. doi: 10.1097/00004630-200101000-00010.
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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.
Xueli Tan, MM, MT-BC study chair
The Cleveland Music School Settlement
Richard B. Fratianne, MD, FACS principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) in people with Pain Management, run by MetroHealth Medical Center 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain, Anxiety, Muscle Tension levels (time frame: 7 data points before, during, after debridement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822497, which also lists 2 linked publications.
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 23 Jul 2010.