Clinical trial NCT06582134: Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students
Official title: Effectiveness of Brief Mindfulness-Based Interventions (BMBI) for Painful Temporomandibular Disorders (TMD) Among University Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders
Chronic Pain
Keywords: Brief mindfulness-based intervention
Temporomandibular disorders
University students
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* Currently on antibiotics or taken antibiotics within the last 2 weeks prior to start of study
* Currently pregnant or lactating women

Primary outcomes:
measure: Degree of Pain Intensity
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
measure: Degree of Limitation of Jaw Function
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
measure: Level of Psychological distress
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
measure: Extent of Impact on Oral-health Related Quality of Life
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
Secondary outcomes:
measure: Mindfulness state
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
Other outcomes:
measure: Width of Mouth Opening
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
measure: Number of Palpation Sites With Pain
timeFrame: Change from Baseline at 2 weeks, 1 month and 3 Months
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Faculty of Dentistry, Universiti Malaya
name: Kathreena Kadir, MClinDent (OMFS)(Mal)
role: STUDY_CHAIR
References:
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citation: Yule PL, Durham J, Playford H, Moufti MA, Steele J, Steen N, Wassell RW, Ohrbach R. OHIP-TMDs: a patient-reported outcome measure for temporomandibular disorders. Community Dent Oral Epidemiol. 2015 Oct;43(5):461-70. doi: 10.1111/cdoe.12171. Epub 2015 Jun 4.
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