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

June 11, 2025 updated by: Razan Baabdullah, King Abdulaziz University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
    • Makkah
      • Jeddah, Makkah, Saudi Arabia
        • Recruiting
        • King Abdulaziz University, Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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.
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.
Other Names:
  • Art-based assessment tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcomes on pain understanding and communication
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: 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).
At baseline and 2-week follow-up.
Temporomandibular Joint (TMJ) Function
Time Frame: 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.
At baseline and 2-week follow-up.
Anxiety level
Time Frame: 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.
At baseline and 2-week follow-up
Depression Screening
Time Frame: 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.
At baseline only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

June 4, 2025

First Submitted That Met QC Criteria

June 11, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-01-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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