Chronic Pain, Temporomandibular Disorders
Conditions
Keywords
Brief mindfulness-based intervention, Temporomandibular disorders, University students
Brief summary
The goal of this clinical trial is to learn if brief mindfulness-based intervention (BMBI) is beneficial to participants suffering from painful temporomandibular disorders (TMD). The objectives of the research are: 1. To compare physical functioning (pain intensity and jaw function) in UM students with chronic pain-related TMD before and after receiving BMBI 2. To compare psychological distress and mindfulness state in UM students with chronic pain-related TMD before and after receiving BMBI 3. To compare the quality of life of UM students with chronic pain-related TMD before and after receiving BMBI 4. To compare the changes in physical functioning, psychological distress, mindfulness state and quality of life between UM students in the intervention (BMBI) and the control groups. Participants will: Listen to the audio recordings 3 times a week, for 3 months when they are about to sleep. Make 4 visits to the clinic: Baseline, 2 weeks, 1 month and 3 months later.
Interventions
BEHAVIORALSham BMBI
Participants are requested to listen to the recordings 3 times a week, for 3 months (in a standardized sequence e.g., 1-2-3 and repeat) on Mondays-Wednesdays-Fridays. They are instructed to listen right before they sleep and encouraged to use them whenever they feel stressed or in pain.
BEHAVIORALBMBI
Participants are requested to listen to the recordings 3 times a week, for 3 months (in a standardized sequence e.g. A-B-C and repeat) on Mondays-Wednesdays-Fridays. They are instructed to listen right before they sleep and encouraged to use them whenever they feel stressed or in pain.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Students attending Universiti Malaya * Able to read and understand English. * Willing and able to give informed consent. * Score 3 and above on the TMD-PS, for at least 3 months.
Exclusion criteria
* Hearing impairment. * Currently on psychiatric follow up and/or taking psychotropic prescriptions (antidepressants, anti-anxiety medications, stimulants, antipsychotics, and mood stabilizers). * Experience with activities similar to the intervention such as meditation, yoga or tai chi. * Currently practicing some form of mindfulness meditation. * History of orofacial trauma, craniofacial pathology, and previous orofacial surgeries (including orthognathic and TMJ) * Systemic rheumatic, neurologic/neuropathic, endocrine (e.g., diabetes mellitus) or immune / autoimmune diseases or widespread pain or being treated with immunosuppressant drugs * Non-TMD orofacial pain disorders * Radiation treatment to head and neck. * Use of narcotic pain medication, muscle relaxants or steroid therapy unless discontinued 1 week before enrolment to study * Use of nonsteroidal anti-inflammatory medications unless the medication(s) were discontinued for 3 days prior to enrolment (use of acetaminophen is allowed as a rescue drug) * Currently on antibiotics or taken antibiotics within the last 2 weeks prior to start of study * Currently pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Pain Intensity | Change from Baseline at 2 weeks, 1 month and 3 Months | * Graded Chronic Pain Scale Version 2.0 (GCPS v2) * 3 items for Characteristic Pain Intensity (CPI), 4 items for Interference Score and 1 item for Disability points for number of days with interference * CPI and Interference Scores are derived from computed mean of items, multiply by 10 * Disability points for number of days with interference is determined from assigned points in a designated table * Total Disability Points = points for Disability Days + points for Interference Score * CPI and Disability Points will determine chronic pain grade (1=none; I=low intensity pain, without disability; II=high intensity pain, without disability; III- moderately limiting; IV=severely limiting) |
| Degree of Limitation of Jaw Function | Change from Baseline at 2 weeks, 1 month and 3 Months | * Jaw Function Limitation Scale (JFLS-8) questionnaire * 8-item global scale for overall functional limitation of the masticatory system * Each item is rated on a numerical rating scale of 0 to 10 (0 indicates no limitation; 10 indicates severe limitation) * Mean of available items will determine degree of limitation |
| Level of Psychological distress | Change from Baseline at 2 weeks, 1 month and 3 Months | * Psychological Distress (PHQ-4) questionnaire * 4 items, each with scores ranging from 0 (not at all) to 3 (nearly every day) * total score ≤2 indicates none-to-minimal levels of depression or anxiety, 3 to 5 indicates mild levels, 6 to 8 indicates moderate levels and ≥9 indicates severe levels |
| Extent of Impact on Oral-health Related Quality of Life | Change from Baseline at 2 weeks, 1 month and 3 Months | * Oral Health Impact Profile-TMD (OHIP-TMD-22) * 22 items tool assessing oral health-related quality of life specific to TMD * Responses are scored from 0-4: never (0), hardly ever (1), occasionally (2), often(3), and very often (4) * Sum of scores ranges from 0 to 88 points, with higher scores indicating poorer quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness state | Change from Baseline at 2 weeks, 1 month and 3 Months | Mindful Attention Awareness Scale (MAAS) * 15 items measure of trait mindfulness. * measures the frequency of open and receptive attention to and awareness of ongoing events and experience. * 6-point Likert scale with responses from almost always (1) to almost never (6). * Results consist of a mean (average) of the 15 items. * higher scores indicate a greater degree of mindfulness |
Countries
Malaysia
Contacts
STUDY_CHAIRKathreena Kadir, MClinDent (OMFS)(Mal)
Faculty of Dentistry, Universiti Malaya
Outcome results
None listed