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

University of Malaya

Status: Enrolling

Conditions: Chronic Pain; Temporomandibular Disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT06582134

DF OS2309/0063 (P)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind