Art-Based Pain Assessment Tool in Patients With Temporomandibular Joint Disorders
NCT ID: NCT07018791
Last Updated: 2025-06-15
Study Results
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Basic Information
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RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2025-04-25
2025-10-30
Brief Summary
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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:
1. Participants will be shown three paintings (e.g., The Scream by Edvard Munch)
2. Participants will choose the one that best resonates with them
3. 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:
1. Does using the APE method help participants better communicate and understand their pain?
2. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
Standard TMD Assessment
This is the conventional diagnostic and management approach for TMD, focusing on physical evaluation and symptom tracking without the use of any visual or art-based tools. It serves as the baseline for comparison in this study.
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.
Standard TMD Assessment
This is the conventional diagnostic and management approach for TMD, focusing on physical evaluation and symptom tracking without the use of any visual or art-based tools. It serves as the baseline for comparison in this study.
Artistic Pain Exploration (APE) Method
This approach involves showing patients three expressive paintings and asking them to select the one that best resonates with them. A guided interview follows, using the artwork to explore the patient's pain characteristics, emotional impact, and functional limitations. This method aims to provide a richer, more personalized understanding of the patient's pain experience.
Interventions
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Standard TMD Assessment
This is the conventional diagnostic and management approach for TMD, focusing on physical evaluation and symptom tracking without the use of any visual or art-based tools. It serves as the baseline for comparison in this study.
Artistic Pain Exploration (APE) Method
This approach involves showing patients three expressive paintings and asking them to select the one that best resonates with them. A guided interview follows, using the artwork to explore the patient's pain characteristics, emotional impact, and functional limitations. This method aims to provide a richer, more personalized understanding of the patient's pain experience.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Presence of severe mental illness, such as psychotic disorders or bipolar affective disorders
* Regular use of narcotic (opioid) pain medications
18 Years
ALL
Yes
Sponsors
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King Abdulaziz University
OTHER
Responsible Party
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Razan Baabdullah
Assistant professor of oral and maxillofacial surgery
Locations
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King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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Al-Khotani A, Naimi-Akbar A, Gjelset M, Albadawi E, Bello L, Hedenberg-Magnusson B, Christidis N. The associations between psychosocial aspects and TMD-pain related aspects in children and adolescents. J Headache Pain. 2016;17:30. doi: 10.1186/s10194-016-0622-0. Epub 2016 Apr 5.
Wilson C, Bungay H, Munn-Giddings C, Boyce M. Healthcare professionals' perceptions of the value and impact of the arts in healthcare settings: A critical review of the literature. Int J Nurs Stud. 2016 Apr;56:90-101. doi: 10.1016/j.ijnurstu.2015.11.003. Epub 2015 Nov 27.
Regev D, Cohen-Yatziv L. Effectiveness of Art Therapy With Adult Clients in 2018-What Progress Has Been Made? Front Psychol. 2018 Aug 29;9:1531. doi: 10.3389/fpsyg.2018.01531. eCollection 2018.
Kirkham JA, Smith JA, Havsteen-Franklin D. Painting pain: an interpretative phenomenological analysis of representations of living with chronic pain. Health Psychol. 2015 Apr;34(4):398-406. doi: 10.1037/hea0000139.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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02-01-25
Identifier Type: -
Identifier Source: org_study_id
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