Assessment of the Impact of Art-Based Pain Assessment Tool on Pain Communication, Joint Function, and Anxiety in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patient-reported outcomes on pain understanding and communication
研究概览
简要总结
Title of Study:
Assessment of the Impact of Art-Based Pain Assessment Tool on Pain Communication, Joint Function, and Anxiety in Patients with Temporomandibular Disorders (TMD): A Randomized Controlled Trial
Location:
King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About?
This study examines how an art-based tool can help improve communication and understanding of pain among patients with jaw joint disorders (TMD). It compares two groups:
- Standard care: Routine diagnostic and therapeutic procedures
- Intervention: Standard care plus a guided art-based tool using paintings to express and discuss the TMD experiences What Is the Art-Based Tool?
This novel method, called the Artistic Pain Exploration (APE), uses paintings to help patients describe their pain that relates to TMD and its effect on their quality of life:
- Participants will be shown three paintings (e.g., The Scream by Edvard Munch)
- Participants will choose the one that best resonates with them
- A guided discussion follows, exploring how the image relates to their physical and emotional pain as well as the effect of pain on their daily activities
Research Questions:
- Does using the APE method help participants better communicate and understand their pain?
- Does it improve jaw function and reduce anxiety more than standard assessment? Who Can Participate?
Participants may be eligible if they:
- Are 18 years or older
- Have early-stage TMD (not needing surgery)
- Can give informed consent
Participants cannot participate if they:
- Require jaw surgery
- Have severe mental illness (e.g., psychosis or bipolar disorder)
- Take narcotic pain medications regularly What Will Happen During the Study?
- Participants are randomly assigned to one of the two groups.
- Each participant will complete a standardized questionnaire before and after two weeks to assess the level of anxiety.
- All participants will be screened for depression via a standardized questionnaire before the first visit.
- All will undergo a clinical exam to assess the TMJ pain and function and receive appropriate medications and lifestyle instructions.
- Some participants (intervention group) will also discuss their pain using the artwork.
- All participants will be seen for a follow up in 2 weeks to assess the TMJ function and pain.
Potential Risks and Discomforts
Participants may experience:
- Emotional discomfort while discussing pain
- Mild anxiety during interviews or questionnaires If needed, a psychiatrist on the research team will provide support or referrals.
Potential Benefits
- A better understanding of pain
- Improved communication with care provider
- Possible improvement in pain and jaw function
Costs There are no costs to participate. All treatments are provided free of charge.
Compensation / Treatment for Injury
- If participants experience harm from this study, necessary medical care will be provided by the research team.
- No financial compensation will be provided by King Abdulaziz University.
Confidentiality Participants' identity and medical records will remain confidential. Only approved researchers and auditors will have access to data, in accordance with applicable laws. Any results published will not include participants' name or identifying details.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Individuals analyzing the results (comparing scores on pain communication, anxiety, and TMJ pain and function) are blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Diagnosed with Temporomandibular Disorders (TMD) requiring conservative management only and classified as Wilkes' stage I or II
- •Able to understand and sign the informed consent form
排除标准
- •Patients requiring surgical intervention for TMD
- •Presence of severe mental illness, such as psychotic disorders or bipolar affective disorders
- •Regular use of narcotic (opioid) pain medications
研究组 & 干预措施
Control Group
Participants in this group receive standard care for Temporomandibular Joint Disorders (TMD), which includes a clinical examination, assessment of pain using the Visual Analogue Scale (VAS), anxiety and depression screening (GAD-7 and PHQ-9), evaluation of jaw pain and function, and conservative treatment through medication and self-care instructions.
干预措施: Standard TMD Assessment (Diagnostic Test)
Intervention Group
Participants in this group receive the same standard care as the control group, with the addition of an art-based method designed to enhance the understanding and communication of pain.
干预措施: Standard TMD Assessment (Diagnostic Test)
Intervention Group
Participants in this group receive the same standard care as the control group, with the addition of an art-based method designed to enhance the understanding and communication of pain.
干预措施: Artistic Pain Exploration (APE) Method (Diagnostic Test)
结局指标
主要结局
Patient-reported outcomes on pain understanding and communication
时间窗: Baseline
The Pain Communication and Understanding Questionnaire is a validated tool designed to assess how well patients understand their own pain and how effectively they are able to communicate that experience with their healthcare provider.
次要结局
- Pain Level(At baseline and 2-week follow-up.)
- Temporomandibular Joint (TMJ) Function(At baseline and 2-week follow-up.)
- Anxiety level(At baseline and 2-week follow-up)
- Depression Screening(At baseline only.)
研究者
Razan Baabdullah
Assistant professor of oral and maxillofacial surgery
King Abdulaziz University