Temporomandibular DisordersNCT06582134
Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students
A study testing BMBI in people with Temporomandibular Disorders and Chronic Pain, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Temporomandibular Disorders, Chronic Pain
- What is being tested?
- BMBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteMalaysia
- Study dates
- 12 Jan 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: 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:
- 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.
Read more
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.
- Conditions
- Temporomandibular Disorders, Chronic Pain
- Being tested
- Sham BMBI, BMBI
- Keywords
- Brief mindfulness-based intervention, Temporomandibular disorders, University students
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham BMBIBehavioural
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.
BMBIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | 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. Receives: Behavioral: Sham BMBI |
| Brief Mindfulness-Based Intervention | Experimental | 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. Receives: Behavioral: BMBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline at 2 weeks, 1 month and 3 Months
Secondary outcomes (1)
Mindfulness state
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
Measured: Change from Baseline at 2 weeks, 1 month and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start12 Jan 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Chan Siew Wui, University of Malaya
- Investigators
- Kathreena Kadir, MClinDent (OMFS)(Mal), Study chair, Faculty of Dentistry, Universiti Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582134
- Sponsor's protocol ID
- DF OS2309/0063 (P)
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.
PubMed 33884400McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.
PubMed 30523705Schumer MC, Lindsay EK, Creswell JD. Brief mindfulness training for negative affectivity: A systematic review and meta-analysis. J Consult Clin Psychol. 2018 Jul;86(7):569-583. doi: 10.1037/ccp0000324.
PubMed 29939051Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Yule 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.
PubMed 26040190Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.
PubMed 22623334
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Brief Mindfulness-Based Interventions (BMBI) for Painful Temporomandibular Disorders (TMD) Among University Students
- ClinicalTrials.gov ID
- NCT06582134
- Acronym / sponsor ID
- DF OS2309/0063 (P)
- Conditions
- Temporomandibular Disorders, Chronic Pain
- Keywords
- Brief mindfulness-based intervention, Temporomandibular disorders, University students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Behavioral: Sham BMBIThree 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. |
| Brief Mindfulness-Based Intervention | Experimental | Behavioral: BMBIThree 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham BMBIParticipants 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. | Behavioural | Control |
| BMBIParticipants 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. | Behavioural | Brief Mindfulness-Based Intervention |
Primary outcome
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
1 secondary outcome
Mindfulness state
Time frame: Change from Baseline at 2 weeks, 1 month and 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 33884400Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.
- Results publication: PubMed 30523705McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.
- Results publication: PubMed 29939051Schumer MC, Lindsay EK, Creswell JD. Brief mindfulness training for negative affectivity: A systematic review and meta-analysis. J Consult Clin Psychol. 2018 Jul;86(7):569-583. doi: 10.1037/ccp0000324.
- Results publication: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Results publication: PubMed 26040190Yule 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.
- Results publication: PubMed 22623334Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.
- Diagnostic Criteria for Temporomandibular Disorders: Scoring Manual for Self-Report Instruments.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathreena Kadir, MClinDent (OMFS)(Mal) study chair
Faculty of Dentistry, Universiti Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMBI in people with Temporomandibular Disorders and Chronic Pain, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Pain Intensity (time frame: Change from Baseline at 2 weeks, 1 month and 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06582134, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.