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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Degree of Pain Intensity [Time frame: 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]
• Level of Psychological distress [Time frame: 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]

Secondary outcome measures (1)

• Mindfulness state [Time frame: Change from Baseline at 2 weeks, 1 month and 3 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Malaysia · 1 center

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

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. PMID 33884400
• 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. PMID 30523705
• 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. PMID 29939051
• 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 PMID 24482784
• 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. PMID 26040190
• 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. PMID 22623334

Identifiers

NCT: NCT06582134 · DF OS2309/0063 (P)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗