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Recruiting NCT07018791

Art-Based Pain Assessment Tool in Patients With Temporomandibular Joint Disorders

Phase III Interventional Temporomandibular Disorders (TMD) Wilkes 1 and 2 TMJ Pain TMJ - Oral &Amp;Maxillofacial Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard TMD Assessment, Artistic Pain Exploration (APE) Method.
Who it may be relevant to
Registry conditions: Temporomandibular Disorders (TMD), Wilkes 1 and 2, TMJ Pain, TMJ - Oral &Amp;Maxillofacial Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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: 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.

Interventions

  • Diagnostic test 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.
  • Diagnostic test 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.

Primary outcome measures

  • Patient-reported outcomes on pain understanding and communication [Time frame: Baseline]
Secondary outcome measures (4)
  • Pain Level [Time frame: At baseline and 2-week follow-up.]
  • Temporomandibular Joint (TMJ) Function [Time frame: At baseline and 2-week follow-up.]
  • Anxiety level [Time frame: At baseline and 2-week follow-up]
  • Depression Screening [Time frame: At baseline only.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Saudi Arabia · 1 center
  • King Abdulaziz University, Faculty of Dentistry — Jeddah

Publications

  • 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. PMID 27044436
  • 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. PMID 26696399
  • 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. PMID 30210388
  • 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. PMID 25822055

Identifiers

NCT: NCT07018791 · 02-01-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗