Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-24 @ 11:24 PM
Study NCT ID:
NCT06582134
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Width of Mouth Opening', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '\\- Measurement of interincisal distance on reference teeth during maximum mouth opening without pain, with pain and with assistance'}, {'measure': 'Number of Palpation Sites With Pain', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '* number of palpation sites (temporomandibular joint and muscles) that is painful\n* muscles palpation: temporalis, masseter, posterior mandibular region, submandibular region, lateral pterygoid area, temporalis tendon)'}], 'primaryOutcomes': [{'measure': 'Degree of Pain Intensity', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '* Graded Chronic Pain Scale Version 2.0 (GCPS v2)\n* 3 items for Characteristic Pain Intensity (CPI), 4 items for Interference Score and 1 item for Disability points for number of days with interference\n* CPI and Interference Scores are derived from computed mean of items, multiply by 10\n* Disability points for number of days with interference is determined from assigned points in a designated table\n* Total Disability Points = points for Disability Days + points for Interference Score\n* 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)'}, {'measure': 'Degree of Limitation of Jaw Function', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '* Jaw Function Limitation Scale (JFLS-8) questionnaire\n* 8-item global scale for overall functional limitation of the masticatory system\n* Each item is rated on a numerical rating scale of 0 to 10 (0 indicates no limitation; 10 indicates severe limitation)\n* Mean of available items will determine degree of limitation'}, {'measure': 'Level of Psychological distress', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '* Psychological Distress (PHQ-4) questionnaire\n* 4 items, each with scores ranging from 0 (not at all) to 3 (nearly every day)\n* 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'}, {'measure': 'Extent of Impact on Oral-health Related Quality of Life', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '* Oral Health Impact Profile-TMD (OHIP-TMD-22)\n* 22 items tool assessing oral health-related quality of life specific to TMD\n* Responses are scored from 0-4: never (0), hardly ever (1), occasionally (2), often(3), and very often (4)\n* Sum of scores ranges from 0 to 88 points, with higher scores indicating poorer quality of life'}], 'secondaryOutcomes': [{'measure': 'Mindfulness state', 'timeFrame': 'Change from Baseline at 2 weeks, 1 month and 3 Months', 'description': '* Five Facet Mindfulness questionnaire (FFMQ-15)\n* 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\n* 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brief mindfulness-based intervention', 'Temporomandibular disorders', 'University students'], 'conditions': ['Temporomandibular Disorders', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33884400', 'type': 'BACKGROUND', 'citation': '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': '30523705', 'type': 'BACKGROUND', 'citation': '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': '29939051', 'type': 'BACKGROUND', 'citation': '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': '24482784', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26040190', 'type': 'BACKGROUND', 'citation': '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': '22623334', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://ubwp.buffalo.edu/rdc-tmdinternational/tmd-assessmentdiagnosis/dc-tmd/', 'label': 'Diagnostic Criteria for Temporomandibular Disorders: Scoring Manual for Self-Report Instruments.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. To compare physical functioning (pain intensity and jaw function) in UM students with chronic pain-related TMD before and after receiving BMBI\n2. To compare psychological distress and mindfulness state in UM students with chronic pain-related TMD before and after receiving BMBI\n3. To compare the quality of life of UM students with chronic pain-related TMD before and after receiving BMBI\n4. 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.\n\nParticipants will:\n\nListen to the audio recordings 3 times a week, for 3 months when they are about to sleep.\n\nMake 4 visits to the clinic: Baseline, 2 weeks, 1 month and 3 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students attending Universiti Malaya\n* Able to read and understand English.\n* Willing and able to give informed consent.\n* Score 3 and above on the TMD-PS, for at least 3 months.\n\nExclusion Criteria:\n\n* Hearing impairment.\n* Currently on psychiatric follow up and/or taking psychotropic prescriptions (antidepressants, anti-anxiety medications, stimulants, antipsychotics, and mood stabilizers).\n* Experience with activities similar to the intervention such as meditation, yoga or tai chi.\n* Currently practicing some form of mindfulness meditation.\n* History of orofacial trauma, craniofacial pathology, and previous orofacial surgeries (including orthognathic and TMJ)\n* Systemic rheumatic, neurologic/neuropathic, endocrine (e.g., diabetes mellitus) or immune / autoimmune diseases or widespread pain or being treated with immunosuppressant drugs\n* Non-TMD orofacial pain disorders\n* Radiation treatment to head and neck.\n* Use of narcotic pain medication, muscle relaxants or steroid therapy unless discontinued 1 week before enrolment to study\n* 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)\n* Currently on antibiotics or taken antibiotics within the last 2 weeks prior to start of study\n* Currently pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT06582134', 'briefTitle': 'Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Effectiveness of Brief Mindfulness-Based Interventions (BMBI) for Painful Temporomandibular Disorders (TMD) Among University Students', 'orgStudyIdInfo': {'id': 'DF OS2309/0063 (P)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Behavioral: Sham BMBI']}, {'type': 'EXPERIMENTAL', 'label': 'Brief Mindfulness-Based Intervention', 'description': '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.', 'interventionNames': ['Behavioral: BMBI']}], 'interventions': [{'name': 'Sham BMBI', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control']}, {'name': 'BMBI', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Brief Mindfulness-Based Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50603', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'facility': 'Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Siew Wui Chan, MClinDent (UM)', 'role': 'CONTACT', 'email': 'swuichan@um.edu.my', 'phone': '+60-379674540'}, {'name': 'Zuraiza Mohamad Zaini, MRACDS (Oral Med), PHD(London)', 'role': 'CONTACT', 'email': 'zuraiza@um.edu.my', 'phone': '+60-379674869'}], 'overallOfficials': [{'name': 'Kathreena Kadir, MClinDent (OMFS)(Mal)', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, Universiti Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr Chan Siew Wui', 'investigatorAffiliation': 'University of Malaya'}}}}