Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students
NCT ID: NCT06582134
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-01-12
2025-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
30 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Dr Chan Siew Wui
Dr.
Principal Investigators
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Kathreena Kadir, MClinDent (OMFS)(Mal)
Role: STUDY_CHAIR
Faculty of Dentistry, Universiti Malaya
Locations
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Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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References
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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.
McClintock 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.
Schumer 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.
Schiffman 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.
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.
Baer 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.
Related Links
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Diagnostic Criteria for Temporomandibular Disorders: Scoring Manual for Self-Report Instruments.
Other Identifiers
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DF OS2309/0063 (P)
Identifier Type: -
Identifier Source: org_study_id
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