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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

history of TMD surgery

neoplasm or injury/trauma to the TMD area

cancer-related pain

scheduled for any surgeries during the study time-frame

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gratitude

    Behavioral

    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 Wellness

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Gratitude InterventionExperimental treatment 1 intervention
Group B: General WellnessActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Participant Retention

Percentage of participants who initiate treatment/intervention and complete the post-intervention assessment at the 4-week time-point.

Time frame
Baseline to Week 4
2

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.

Time frame
Week 4

Secondary outcomes

1

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.

Time frame
Baseline, Week 4
2

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.

Time frame
Baseline, Week 4

Other outcomes

Sponsors and contacts

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