What Are the Effects of Music on Temporomandibular Disorder Symptoms? (TMD)
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|ClinicalTrials.gov Identifier: NCT02427113|
Recruitment Status : Unknown
Verified May 2016 by Alicia Howard, University of Toronto.
Recruitment status was: Recruiting
First Posted : April 27, 2015
Last Update Posted : May 12, 2016
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|Condition or disease||Intervention/treatment||Phase|
|TMD||Other: Sound Oasis Vibrating Chair Other: Self-Select Music||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||What Are the Effects of Music on TMD Symptoms?|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
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.
Other: Self-Select Music
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.
Other: Sound Oasis Vibrating Chair
Sound oasis vibroacoustic chair will be used as treatment for managing TMD related pain
- 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.
- Short Inventory Depression Scale [ Time Frame: 3 months ]
- Mult-Dimensional Mood Questionnaire [ Time Frame: 3 months ]
- Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: 3 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
- Hemorrhaging or Active Bleeding
- Pacemakers as contraindications of Vibroacoustic Therapy (VAT) are related to these conditions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427113
|Contact: Allan Gordon, PhD||416-586-5181|
|Contact: Alicia A Howard, PhD Candiateemail@example.com|
|Mount Sinai Hospital's Wasser Pain Management Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Allan Gordon, PhD 416-586-5181|
|Principal Investigator:||Dr. Allan Gordon, PhD||MOUNT SINAI HOSPITAL|
|Responsible Party:||Alicia Howard, PhD Candidate, University of Toronto, University of Toronto|
|Other Study ID Numbers:||
|First Posted:||April 27, 2015 Key Record Dates|
|Last Update Posted:||May 12, 2016|
|Last Verified:||May 2016|