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

Phase 3

Recruiting

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

• Registration Number: NCT07018791
• Lead Sponsor: King Abdulaziz University

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-25
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-reported outcomes on pain understanding and communication	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.

Secondary Outcome Measures

Name	Time	Method
Pain Level	At baseline and 2-week follow-up.	Measured by the Visual Analogue Scale (VAS), this outcome captures the intensity of pain as reported by the patient on a scale from 0 (no pain) to 10 (worst pain imaginable).
Temporomandibular Joint (TMJ) Function	At baseline and 2-week follow-up.	TMJ functional capacity will be evaluated through a set of clinical assessments: Maximal interincisal distance (mm): measured as the maximum unassisted vertical opening between the incisal edges of upper and lower central incisors using a calibrated ruler or caliper.; Mandibular excursive and protrusive movements (mm): lateral and anterior movements will be measured from centric occlusion to maximum displacement.; Pain on mouth opening (VAS 0-10): Participants will rate pain intensity during maximum mouth opening using a 10-point visual analog scale.; Presence of joint sounds (clicking/crepitus): assessed through bilateral palpation and auscultation during mandibular motion; recorded as Present or Absent.; Presence of occlusal wear facets: identified through intraoral examination; recorded as Present or Absent.; Muscle of mastication tenderness: evaluated via bilateral palpation of the muscles of mastication and recorded as tender or non-tender.
Anxiety level	At baseline and 2-week follow-up	Assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire, this outcome indicates the severity of anxiety symptoms experienced by the patient. The minimum score is zero and the maximum is 21. Lower scores mean lower anxiety levels.
Depression Screening	At baseline only.	Screened at baseline using the Patient Health Questionnaire-9 (PHQ-9), this outcome identifies the presence and severity of depressive symptoms in the patient. The minimum score is zero and the maximum is 27. Lower PHQ-9 scores indicate fewer or less severe depressive symptoms.

Trial Locations

Locations (1)

King Abdulaziz University, Faculty of Dentistry; 🇸🇦 Jeddah, Makkah, Saudi Arabia