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NCT Number: NCT06582134

Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students

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.

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Key information

Conditions

Temporomandibular Disorders Chronic Pain Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham BMBI

Behavioral

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.

BMBI

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  1. Mindfulness state

    Time frame: Change from Baseline at 2 weeks, 1 month and 3 Months

    • 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.

Other outcomes

  1. Width of Mouth Opening

    Time frame: Change from Baseline at 2 weeks, 1 month and 3 Months

    • Measurement of interincisal distance on reference teeth during maximum mouth opening without pain, with pain and with assistance

  2. Number of Palpation Sites With Pain

    Time frame: Change from Baseline at 2 weeks, 1 month and 3 Months

    • 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Siew Wui Chan, MClinDent (UM)

CONTACT

[email protected]

+60-379674540

Zuraiza Mohamad Zaini, MRACDS (Oral Med), PHD(London)

CONTACT

[email protected]

+60-379674869

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Effectiveness of Brief Mindfulness-Based Interventions (BMBI) for Painful Temporomandibular Disorders (TMD) Among University Students

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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