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

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: Recruiting
• Conditions: Chronic Pain; Temporomandibular Disorders

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siew Wui Chan, MClinDent (UM); Phone Number: +60-379674540; Email: swuichan@um.edu.my
• Study Contact Backup: Name: Zuraiza Mohamad Zaini, MRACDS (Oral Med), PHD(London); Phone Number: +60-379674869; Email: zuraiza@um.edu.my

Participation Criteria

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

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width of Mouth Opening	- 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	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

• Sponsor: University of Malaya

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Diagnostic Criteria for Temporomandibular Disorders: Scoring Manual for Self-Report Instruments.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): September 1, 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 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Temporomandibular disorders; University students; Brief mindfulness-based intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Chronic Pain; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• 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