Clinical trial NCT07018791: Art-Based Pain Assessment Tool in Patients With Temporomandibular Joint Disorders
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Patient-reported outcomes on pain understanding and communication
timeFrame: Baseline
Secondary outcomes:
measure: Pain Level
timeFrame: At baseline and 2-week follow-up.
measure: Temporomandibular Joint (TMJ) Function
timeFrame: At baseline and 2-week follow-up.
measure: Anxiety level
timeFrame: At baseline and 2-week follow-up
measure: Depression Screening
timeFrame: At baseline only.
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University, Faculty of Dentistry
state: Makkah
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.