Actively Recruiting

Phase Not Applicable
Age: 18Years - 30Years
All Genders
ID06582134

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

Led by University of Malaya · Updated on 2024-09-04

50

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a brief mindfulness-based intervention (BMBI) can help university students suffering from painful temporomandibular disorders (TMD) with chronic pain. The study aims to compare physical function, psychological distress, mindfulness, and quality of life before and after the intervention, as well as between students receiving BMBI and those in a control group. The study is designed as a randomized, double-blind trial led by the University of Malaya. Participants are divided into two groups: one listens to three 10-minute audio recordings containing mindfulness training based on breathing exercises, and the other listens to relaxing music recordings without mindfulness instructions. Both groups listen to these audio recordings three times a week for three months, typically before sleep. The study includes four clinic visits: at baseline, 2 weeks, 1 month, and 3 months. During the study, participants will be assessed for changes in pain intensity, jaw function, psychological distress, mindfulness state, and oral-health related quality of life at 2 weeks, 1 month, and 3 months. These assessments help measure the impact of the intervention. The total participation spans the three-month period with regular monitoring and follow-up clinic visits to evaluate outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Hearing impairment
  • Currently on psychiatric follow up or taking psychotropic medications
  • Experience with meditation, yoga, tai chi, or similar activities
  • Currently practicing mindfulness meditation
  • History of orofacial trauma, craniofacial pathology, or orofacial surgeries
  • Systemic rheumatic, neurologic/neuropathic, endocrine, immune/autoimmune diseases or widespread pain
  • Use of immunosuppressants
  • Non-TMD orofacial pain disorders
  • Radiation treatment to head and neck
  • Use of narcotic pain medication, muscle relaxants, or steroids unless discontinued 1 week before
  • Use of nonsteroidal anti-inflammatory drugs unless discontinued 3 days before (acetaminophen allowed)
  • Currently on antibiotics or taken antibiotics within 2 weeks prior to study
  • Currently pregnant or lactating women

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 3 months

Participants listen to brief mindfulness-based audio recordings or sham recordings three times a week for 3 months, typically right before sleep, to help manage painful temporomandibular disorders and related symptoms.

Weekly visits for monitoring adherence and progress

Trial Site Locations

Total: 1 location

1

Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia, 50603

Actively Recruiting

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Research Team

S

Siew Wui Chan, MClinDent (UM)

Z

Zuraiza Mohamad Zaini, MRACDS (Oral Med), PHD(London)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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 Group†.

Eric Schiffman, Richard Ohrbach, Edmond Truelove...

https://pubmed.ncbi.nlm.nih.gov/24482784