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

NCT07018791 | Recruiting Phase 3 DMC

• 1 other identifier: 02-01-25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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
• 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?
• 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.

Conditions

Temporomandibular Disorders (TMD); Wilkes 1 and 2; TMJ Pain; TMJ - Oral &Amp;Maxillofacial Surgery; Art Therapy; TMD Art Pain Study

Keywords

Temporomandibular joint disorders; Artistic Pain Exploration (APE); Visual Pain Expression; Art-Based Assessment; Multisensory Pain Assessment; Randomized Controlled Trial; Pain Communication; Patient-Reported Outcomes; TMJ Function

Outcome Measures

Primary Outcomes (1)

• Patient-reported outcomes on pain understanding and communication

  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.

  Baseline

Secondary Outcomes (4)

• 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.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Diagnostic Test: Standard TMD Assessment

Intervention Group

EXPERIMENTAL

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.

Diagnostic Test: Standard TMD Assessment; Diagnostic Test: Artistic Pain Exploration (APE) Method

Interventions

Standard TMD Assessment DIAGNOSTIC_TEST

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.

Control Group; Intervention Group

Artistic Pain Exploration (APE) Method DIAGNOSTIC_TEST

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.

Also known as: Art-based assessment tool

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Faculty of Dentistry

Jeddah, Mecca Region, Saudi Arabia

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Razan M Baabdullah, BDS, MS, FRCDC

CONTACT

+96655501567; rmsbaabdullah@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals analyzing the results (comparing scores on pain communication, anxiety, and TMJ pain and function) are blinded to group allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of oral and maxillofacial surgery

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: April 25, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

SA (1)