- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427113
What Are the Effects of Music on Temporomandibular Disorder Symptoms? (TMD)
What Are the Effects of Music on TMD Symptoms?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators hypothesize that patients will experience less pain, an elevation in mood, a decrease in stress, higher well-being, and a reduction in TMD symptoms after receiving therapeutic music treatments. The investigators further predict that the vibrations generated by the Sound Oasis VTS1000 (vibroacoustic chair) will produce stronger effects than self-selected music. The question to be investigated in this study: "What are the effects of music on TMD symptoms?"
Participant intake will occur prior to study providing information on diagnostics, music preferences, participant demographics, and participant randomization. The study will consist of 4 assessments and 2 treatments with a 1 month wash-out period between treatments. Assessment 1 (will serve as pre-test) and occur before 1st treatment. Assessment 2 (will serve as post-test), taking place before 2nd treatment and will last 45 minutes. Assessment 3 will follow the wash-out period; and assessment 4 (the final session), which will be a total of 60 minutes will include a participant treatment review interview. Pre/post assessments will be utilized as a means to examine change in pain at the level of each participant, mood levels, depression and the perception of quality of life.
Therapeutic music treatments, which will consist of randomly assigned interventions of Sound Oasis VTS-1000 and preferred music playlist, will be prescribed for self-administered in-home sessions for 3-weeks, 7 days (recommended) but at least a minimum of 5 days per week. During each 3-week music treatment period, 1 self-administered in-home music treatment will be prescribed for 3-weeks, 7 days (recommended) but at least a minimum of 5 days per week.
There will be 2 times where the participants receive no therapeutic music intervention but will continue with treatment as usual which will occur 7 days prior to each treatment. Participants will be asked to do a daily pain rating for one week during treatment as usual before the start of the music interventions.
There will be a 4-week wash-out period between therapeutic music treatments 1 and 2. There will be no music treatment during this time. Participants will be asked to keep a record of the type of medication taken, a pill count, and frequency of medication during this time as well as during treatment.
Both therapeutic music and treatment as usual times will be intervened by a treatment compliance email or phone call by the music therapist. Participants will be randomly assigned to 2 groups: (a) Sound Oasis VTS-1000 and (b) participant preferred music. Participants will complete questionnaires at the beginning of the study, following the end of the first 3 weeks of either therapeutic music treatment, at the end of the second 3 weeks of therapeutic music and during the final assessment time, which will also consist of a brief interview about treatment received.
Data will be analyzed with reference given only to an assigned ID number. All information collected will be used for this study to investigate the effects of therapeutic music on the management of TMD symptoms. Furthermore, all participants will be informed that all information that will be disclosed will remain confidential, unless the disclosed information will cause harm to self or others.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Allan Gordon, PhD
- Phone Number: 416-586-5181
Study Contact Backup
- Name: Alicia A Howard, PhD Candiate
- Phone Number: 905-617-0386
- Email: alicia.howard@mail.utoronto.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Recruiting
- Mount Sinai Hospital's Wasser Pain Management Centre
-
Contact:
- Allan Gordon, PhD
- Phone Number: 416-586-5181
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hearing able as listening to music is required as part of treatment
- main source of pain is myofascial pain
- on-going pain for 6 months
Exclusion Criteria:
- Acute Inflammatory Conditions - an inflammation having a rapid onset, with a clear and distinct termination. (e.g. Rheumatoid arthritis and Osteoarthritis)
- Clients Presenting with Psychoses
- Pregnancy
- Hemorrhaging or Active Bleeding
- Thrombosis
- Hypotension
- Pacemakers as contraindications of Vibroacoustic Therapy (VAT) are related to these conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Self-Select Music
Participants will be randomized to two groups.
Self-select music will be used as treatment for managing pain.
They will be required to listen to their preferred songs for 30 minutes per 7 days, recommended 5, for 3 weeks.
|
The self-select music of the participants will be applied for managing the painful symptoms of TMD
|
ACTIVE_COMPARATOR: Sound Oasis Vibrating Chair
Participants will be randomized to two groups.
Vibroacoustic therapy will be administered in the form of a vibrating chair.
They will be required to listen to their preferred songs for 30 minutes per 7 days, recommended 5, for 3 weeks.
|
Sound oasis vibroacoustic chair will be used as treatment for managing TMD related pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale to measure pain levels
Time Frame: 3 months
|
A psychometric response scale which can be used in questionnaires to measure participants pain levels.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Short Inventory Depression Scale
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mult-Dimensional Mood Questionnaire
Time Frame: 3 months
|
3 months
|
Quality of Life Enjoyment and Satisfaction Questionnaire
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Allan Gordon, PhD, Mount Sinai Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZurichUAS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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