Clinical trial NCT02427113: What Are the Effects of Music on Temporomandibular Disorder Symptoms?
Official title: What Are the Effects of Music on TMD Symptoms?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TMD
Keywords: TMD
Music Medicine
Vibroacousitc Therapy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2015-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale to measure pain levels
timeFrame: 3 months
Secondary outcomes:
measure: Short Inventory Depression Scale
timeFrame: 3 months
Other outcomes:
measure: Mult-Dimensional Mood Questionnaire
timeFrame: 3 months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: 3 months
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital's Wasser Pain Management Centre
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Dr. Allan Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: