Temporomandibular Disorders (TMD)Phase 3NCT07018791
Art-Based Pain Assessment Tool in Patients With Temporomandibular Joint Disorders
A Phase 3 study testing Standard TMD Assessment and Artistic Pain Exploration (APE) Method in people with Temporomandibular Disorders (TMD) and Wilkes 1 and 2, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders (TMD), Wilkes 1 and 2, TMJ Pain
- What is being tested?
- Standard TMD Assessment and Artistic Pain Exploration (APE) Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Apr 2025to 30 Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region
Haneen Shaaban, MSc, +966126400000, den-rec@kau.edu.sa
About this study
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
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
Read more
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
Research Questions:
- 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?
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.
- Conditions
- Temporomandibular Disorders (TMD), Wilkes 1 and 2, TMJ Pain, TMJ - Oral &Amp;Maxillofacial Surgery, Art Therapy, TMD Art Pain Study
- Being tested
- Standard TMD Assessment, Artistic Pain Exploration (APE) Method
- 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
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TMD AssessmentDiagnostic 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.
Artistic Pain Exploration (APE) MethodDiagnostic test
Also called Art-based assessment tool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Standard TMD Assessment; Diagnostic Test: Artistic Pain Exploration (APE) Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Pain Level
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).
Measured: At baseline and 2-week follow-up.
Temporomandibular Joint (TMJ) Function
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.
Measured: At baseline and 2-week follow-up.
Anxiety level
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.
Measured: At baseline and 2-week follow-up
Depression Screening
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.
Measured: At baseline only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start25 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razan Baabdullah, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018791
- Sponsor's protocol ID
- 02-01-25
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27044436Wilson 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.
PubMed 26696399Regev 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.
PubMed 30210388Kirkham 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.
PubMed 25822055
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07018791
- Acronym / sponsor ID
- 02-01-25
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Research Questions:
- 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?
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Standard TMD AssessmentParticipants 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. |
| Intervention Group | Experimental | Diagnostic Test: Standard TMD Assessment, Diagnostic Test: Artistic Pain Exploration (APE) MethodParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TMD AssessmentThis 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 | Control Group, Intervention Group |
| Artistic Pain Exploration (APE) MethodAlso: Art-based assessment toolThis 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. | Diagnostic test | Intervention Group |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 27044436Al-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.
- Results publication: PubMed 26696399Wilson 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.
- Results publication: PubMed 30210388Regev 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.
- Results publication: PubMed 25822055Kirkham 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard TMD Assessment and Artistic Pain Exploration (APE) Method in people with Temporomandibular Disorders (TMD) and Wilkes 1 and 2, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Razan M Baabdullah, BDS, MS, FRCDC (+96655501567, rmsbaabdullah@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcomes on pain understanding and communication (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018791, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.