Temporomandibular Disorders (TMD)NCT06977100
Journaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain
A study testing Gratitude and General Wellness in people with Temporomandibular Disorders (TMD), run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Gratitude and General Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Melissa Makhoul, Phd, MSN, RN, 352-246-3153, melissamakhoul@ufl.edu
About this study
Official title: Examining the Feasibility and Acceptability of a Journaling Intervention in Alleviating Temporomandibular Pain
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:
Read more
- 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.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Gratitude, General Wellness
- Keywords
- Temporomandibular Disorder, Gratitude Journaling, Resilience, Pain Intensity, Pain Interference, Chronic Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GratitudeBehavioural
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.
General WellnessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gratitude Intervention | Experimental | Not described Receives: Behavioral: Gratitude |
| General Wellness | Active comparator | Not described Receives: Other: General Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention
Percentage of participants who initiate treatment/intervention and complete the post-intervention assessment at the 4-week time-point.
Measured: Baseline to Week 4
Treatment Satisfaction
Single-item Treatment Satisfaction Questionnaire: Response to self-reported item assessing overall satisfaction with the treatment. The item is rated on a 1 to 4 scale (1 = Quite Dissatisfied to 4 = Very Satisfied) with the mean value calculated. A higher score indicates greater satisfaction with the treatment.
Measured: Week 4
Secondary outcomes (2)
Pain Intensity
The PROMIS-Pain Intensity short form is a 3-item measure assessing pain intensity over the past 7 days (i.e., "how intense was your pain at its worst"), as well as current level of pain. The total score for the PROMIS Pain Intensity short form will be calculated by summing the numerical values of the responses to each of the three items. After obtaining the total raw score, it will then be converted into a T-score, which standardizes the score with a mean of 50 and a standard deviation of 10, based on the general U.S. population.
Measured: Baseline, Week 4
Pain Interference
The PROMIS-Pain Interference short form is an 8-item measure assessing the extent to which pain interferes with physical, mental, cognitive, emotional, recreational and social activities over the past 7 days (i.e., "how much did pain interfere with work around home"). The total score for the PROMIS-Pain Interference short form will be calculated by summing the numerical values of the responses to each of the eight items. After obtaining the total raw score, it will then be converted into a T-score, which standardizes the score with a mean of 50 and a standard deviation of 10, based on the general U.S. population.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start11 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977100
- Sponsor's protocol ID
- IRB202500344
- Status last verified
- Jun 2026
- First submitted
- 8 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No