Journaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain

Study Purpose

The goal of this clinical trial is to learn whether a 2-week gratitude journaling activity is feasible and acceptable for individuals with Temporomandibular Disorder (TMD) and chronic overlapping pain. The study will also look at whether this activity is helpful in reducing pain and how much it interferes with daily life. The primary aims of this study are to:

  • - Assess whether individuals with TMD and chronic overlapping pain are able to complete the 2-week gratitude journaling activity as planned (feasibility).
  • - Evaluate how acceptable participants find the gratitude journaling activity (acceptability).
The secondary aim of this study is to: • Explore whether the gratitude journaling activity reduces pain and its impact on daily life, compared to a general wellness journaling activity. Participants will:
  • - Attend two in-person visits to complete questionnaires and take part in tests that measure how sensitive they are to pressure and heat.
  • - Complete a 2-week journaling activity at home, writing in their journal on three days of their choice per week.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - participants between the ages of 18 and 80.
  • - pain in the temporomandibular (TMD) region (jaw and/or temple area) - duration of pain is at least 3 months.
  • - average pain score ≥4 on a 0-10 numerical rating scale over the past week.
  • - have at least one additional chronic overlapping pain condition (COPC) including fibromyalgia, irritable bowel syndrome, migraine-type headache, tension-type headache, low back pain, interstitial cystitis/painful bladder syndrome or chronic prostatitis, myalgic encephalomyelitis/chronic fatigue syndrome, vulvodynia, and painful endometriosis.
  • - able to read, understand, and write in English.

Exclusion Criteria:

  • - history of TMD surgery.
  • - neoplasm or injury/trauma to the TMD area.
  • - cancer-related pain.
  • - scheduled for any surgeries during the study time-frame.
  • - current participation in another clinical trial or psychological treatment for any pain-related condition that would interfere with study outcomes.
  • - pregnant or lactating.
  • - severe motor impairments (e.g., muscular dystrophy) - severe psychiatric conditions (e.g., uncontrolled mood disorders) - severe neurological or cognitive impairments (e.g., uncontrolled Parkinson's disease) - any other conditions that in the opinion of study investigators could make participation in the study unsafe.
- use of opioids within 48 hours prior to laboratory visit

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06977100
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Temporomandibular Disorders (TMD)
Arms & Interventions

Arms

Experimental: Gratitude Intervention

Active Comparator: General Wellness

Interventions

Behavioral: - Gratitude

Participants in this group will receive a gratitude journal where they will be asked to write down three things they are grateful for each day and reflect why they are grateful for these things. Journaling will take place from the comfort of their home on three days of their choice per week, for a total duration of two weeks.

Other: - General Wellness

Participants in this group will receive a general wellness journal where they will be asked to reflect on three things that happened, or they did during the day (daily activities). Journaling will take place from the comfort of their home on three days of their choice per week, for a total duration of two weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida

Status

Address

University of Florida

Gainesville, Florida, 32610

Site Contact

Melissa Makhoul, Phd, MSN, RN

[email protected]

352-246-3153