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Идёт набор NCT06977100

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

Без фазы С лечением Temporomandibular Disorders (TMD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Gratitude, General Wellness.
Кому может быть актуально
Состояния в реестре: Temporomandibular Disorders (TMD). Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Examining the Feasibility and Acceptability of a Journaling Intervention in Alleviating Temporomandibular Pain

Обзор

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.

Вмешательства

  • Поведенческое 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.
  • Другое 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.

Первичные конечные точки

  • Participant Retention [Срок оценки: Baseline to Week 4]
  • Treatment Satisfaction [Срок оценки: Week 4]
Вторичные конечные точки (2)
  • Pain Intensity [Срок оценки: Baseline, Week 4]
  • Pain Interference [Срок оценки: Baseline, Week 4]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Florida — Gainesville

Идентификаторы

NCT: NCT06977100 · IRB202500344

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗