Effectiveness of Brief Mindfulness-Based Interventions (BMBI) for Painful Temporomandibular Disorders (TMD) Among University Students
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Temporomandibular Disorders
- Sponsor
- University of Malaya
- Enrollment
- 50
- Primary Endpoint
- Degree of Pain Intensity
- Status
- Recruiting
- Last Updated
- last year
Overview
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:
- To compare physical functioning (pain intensity and jaw function) in UM students with chronic pain-related TMD before and after receiving BMBI
- To compare psychological distress and mindfulness state in UM students with chronic pain-related TMD before and after receiving BMBI
- To compare the quality of life of UM students with chronic pain-related TMD before and after receiving BMBI
- 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.
Investigators
Dr Chan Siew Wui
Dr.
University of Malaya
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Degree of Pain Intensity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Mindfulness state(Change from Baseline at 2 weeks, 1 month and 3 Months)