Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students
NCT Number: NCT06582134
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Disorders|Chronic Pain
Sponsor: University of Malaya
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-12
Completion Date: 2025-09

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.

Primary Outcome Measures: Degree of Pain Intensity, * 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), Change from Baseline at 2 weeks, 1 month and 3 Months|Degree of Limitation of Jaw Function, * 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, Change from Baseline at 2 weeks, 1 month and 3 Months|Level of Psychological distress, * 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, Change from Baseline at 2 weeks, 1 month and 3 Months|Extent of Impact on Oral-health Related Quality of Life, * 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, Change from Baseline at 2 weeks, 1 month and 3 Months
Secondary Outcome Measures: Mindfulness state, * Five Facet Mindfulness questionnaire (FFMQ-15)
* 15 items assessing 5 facets (Observing, Describing, Acting with Awareness, Non-Judging of inner experience, Non-Reactivity to inner experience), with 3 items per facet
* Results consist of a total average score and five subscales. Average scores are calculated by summing the responses and dividing by the number of items and indicate the average level of agreement with each subscale (1 = rarely true, 5 = always true). Higher scores indicate greater mindfulness., Change from Baseline at 2 weeks, 1 month and 3 Months
Other Outcome Measures: Width of Mouth Opening, - Measurement of interincisal distance on reference teeth during maximum mouth opening without pain, with pain and with assistance, Change from Baseline at 2 weeks, 1 month and 3 Months|Number of Palpation Sites With Pain, * number of palpation sites (temporomandibular joint and muscles) that is painful
* muscles palpation: temporalis, masseter, posterior mandibular region, submandibular region, lateral pterygoid area, temporalis tendon), Change from Baseline at 2 weeks, 1 month and 3 Months