TMD Clinical Trial
Official title:
What Are the Effects of Music on TMD Symptoms?
The purpose of the study will be to examine the effectiveness of an innovative use of music on TMD. Music and rhythmic vibrations can alter the basic processes related to sensation of pain in the brain. As well, music can block the neurological pathways that transmit pain sensations and thereby reduce pain. Music and vibrations are relaxing, reduce stress, and thereby reduce sensitivity to pain.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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