Examining the Feasibility and Acceptability of a Journaling Intervention in Alleviating Temporomandibular Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant Retention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Gratitude Intervention
干预措施: Gratitude (Behavioral)
General Wellness
干预措施: General Wellness (Other)
结局指标
主要结局
Participant Retention
时间窗: Baseline to Week 4
Percentage of participants who initiate treatment/intervention and complete the post-intervention assessment at the 4-week time-point.
Treatment Satisfaction
时间窗: Week 4
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.
次要结局
- Pain Intensity(Baseline, Week 4)
- Pain Interference(Baseline, Week 4)