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

August 30, 2026 updated by: Dr Chan Siew Wui, University of Malaya

Effectiveness of Brief Mindfulness-Based Interventions (BMBI) for Painful Temporomandibular Disorders (TMD) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Three 10-minute audio recordings (1, 2, 3) in MPEG-1 Audio Layer 3 (MP3) format consisting of relaxing music that mimic BMBI in duration but do not contain instructions specific to mindfulness training.
Behavioral: Sham 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.
Experimental: Brief Mindfulness-Based Intervention
Three 10-minute audio recordings (A,B,C) for BMBI in MPEG-1 Audio Layer 3 (MP3) format that contain mindfulness training based on the breathing concept in a background of relaxing music.
Behavioral: BMBI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline at 2 weeks, 1 month and 3 Months
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
Change from Baseline at 2 weeks, 1 month and 3 Months
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
Change from Baseline at 2 weeks, 1 month and 3 Months
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
Change from Baseline at 2 weeks, 1 month and 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness state
Time Frame: 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
Change from Baseline at 2 weeks, 1 month and 3 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at 2 weeks, 1 month and 3 Months
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)
Change from Baseline at 2 weeks, 1 month and 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Chair: Kathreena Kadir, MClinDent (OMFS)(Mal), Faculty of Dentistry, Universiti Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

August 29, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF OS2309/0063 (P)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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