TMDTMDNCT02427113
What Are the Effects of Music on Temporomandibular Disorder Symptoms?
A study testing Sound Oasis Vibrating Chair and Self-Select Music in people with TMD, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- TMD
- What is being tested?
- Sound Oasis Vibrating Chair and Self-Select Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Jul 2016
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Allan Gordon, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital's Wasser Pain Management Centre
Toronto, Ontario
Allan Gordon, PhD, 416-586-5181
About this study
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.
Read the 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.
- Conditions
- TMD
- Being tested
- Sound Oasis Vibrating Chair, Self-Select Music
- Keywords
- TMD, Music Medicine, Vibroacousitc Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound Oasis Vibrating ChairOther
Sound oasis vibroacoustic chair will be used as treatment for managing TMD related pain
Self-Select MusicOther
The self-select music of the participants will be applied for managing the painful symptoms of TMD
| Study group | Role | What they receive |
|---|---|---|
| Self-Select Music | Active comparator | 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. Receives: Other: Self-Select Music |
| Sound Oasis Vibrating Chair | Active comparator | 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. Receives: Other: Sound Oasis Vibrating Chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale to measure pain levels
A psychometric response scale which can be used in questionnaires to measure participants pain levels.
Measured: 3 months
Secondary outcomes (1)
Short Inventory Depression Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Responsible party
- Principal investigator, Alicia Howard, University of Toronto
- Investigators
- Dr. Allan Gordon, PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427113
- Sponsor's protocol ID
- ZurichUAS
- Acronym
- TMD
- Status last verified
- May 2016
- First submitted
- 25 Mar 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Effects of Music on TMD Symptoms?
- ClinicalTrials.gov ID
- NCT02427113
- Acronym / sponsor ID
- TMD / ZurichUAS
- Conditions
- TMD
- Keywords
- TMD, Music Medicine, Vibroacousitc Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Study start
- May 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 27 Apr 2015 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Select Music | Active comparator | Other: Self-Select MusicParticipants 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. |
| Sound Oasis Vibrating Chair | Active comparator | Other: Sound Oasis Vibrating ChairParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Sound Oasis Vibrating ChairSound oasis vibroacoustic chair will be used as treatment for managing TMD related pain | Other | Sound Oasis Vibrating Chair |
| Self-Select MusicThe self-select music of the participants will be applied for managing the painful symptoms of TMD | Other | Self-Select Music |
Primary outcome
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.
1 secondary outcome
Short Inventory Depression Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
Allan Gordon, PhD contact
Dr. Allan Gordon, PhD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound Oasis Vibrating Chair and Self-Select Music in people with TMD, run by University of Toronto at 1 site in Canada.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Gordon, PhD (416-586-5181), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale to measure pain levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2016.