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
Phase: PHASE3
Conditions: Temporomandibular Disorders (TMD), Wilkes 1 and 2, TMJ Pain, TMJ - Oral &Amp;Maxillofacial Surgery, Art Therapy, TMD Art Pain Study
Sponsor: King Abdulaziz University

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 
Study Protocol and Statistical Analysis Plan 
ClinicalTrials.gov Identifier (NCT Number): Pending Registration 
Document Date: June 4, 2025 
Institution: 
King Abdulaziz University Faculty of Dentistry (KAUFD) 
Jeddah, Saudi Arabia 
Principal Investigator: 
Razan Mohammad Baabdullah, BDS, MS, FRCDC 
Oral and Maxillofacial Surgeon 
Assistant Professor of Oral and Maxillofacial Surgery 
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry 
King Abdulaziz University, Jeddah, Saudi Arabia  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
Background and Rationale: 
Temporomandibular Disorders (TMD) are commonly treated with pharmacological and 
conservative methods; however, these often neglect the psychosocial dimensions of chronic pain. 
The Artistic Pain Exploration (APE) method, an art-based diagnostic tool, offers a novel 
approach to enhancing pain communication and patient understanding. 
Objectives: 
Primary: To assess the effectiveness of the APE method in improving patient understanding and 
communication of pain. 
Secondary: To evaluate the impact of the APE method on TMJ function, pain intensity, and 
anxiety levels over a 2-week period. 
Study Design: 
Single-blind, randomized controlled trial conducted at King Abdulaziz University Dental 
Hospital from April 2025 to November 2025. 
Participants: 
Inclusion Criteria: Adults ≥18 years old, diagnosed with Wilkes stage I or II TMD, able to 
provide informed consent. 
Exclusion Criteria: Need for surgical intervention, diagnosed severe mental illness (e.g., 
psychosis, bipolar disorder), regular narcotic use. 
Sample Size Calculation: 
To determine the appropriate sample size, a calculation was performed using GPower (Faul, F., 
Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). GPower 3: A flexible statistical power analysis 
program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 
175–191. https://doi.org/10.3758/BF03193146). This analysis was based on repeated-measures 
ANOVA, as the study design includes two groups (intervention and control) and two 
measurement points (baseline and follow-up). We assumed a small to medium effect size (f = 
0.2), an alpha of 0.05, and a statistical power of 0.80. A moderate correlation between repeated 
measures was also assumed. The analysis indicated that a total sample size of 52 would be 
required, with 26 participants per group. However, we will recruit 35 participants per group to 
account for potential loss to follow-up and missing data. 
Randomization and Blinding: 
Simple randomization with allocation concealment using sealed opaque envelopes. Outcome 
assessors and data analysts are blinded to group assignment. 
Intervention: 
Control Group: Receives standard care for TMD, including clinical examination, Visual 
Analogue Scale (VAS), Anxiety level (GAD-7), Screening for depression (PHQ-9), TMJ 
function, and conservative management.  
Intervention Group: Receives standard care plus the Artistic Pain Exploration (APE) method. 

Patients select a painting that resonates best with them and engage in a guided interview based 
on that selection to discuss pain characteristics and its effect of daily life.  
Data Collection: 
At baseline and 2-week follow-up: 
• 
Demographics and medical history 
• 
Pain level (VAS) 
• 
Anxiety (GAD-7) 
• 
Depression (PHQ-9, baseline only) 
• 
TMJ function  
• 
Pain Communication and Understanding Questionnaire (baseline only) 
Outcome Measures: 
• 
Primary: Pain communication and understanding 
• 
Secondary: TMJ Pain, TMJ function, GAD-7 anxiety score, PHQ-9 depression score 
Statistical Analysis Plan 
Descriptive statistics will be calculated for all baseline characteristics. Continuous variables will 
be presented as means and standard deviations, while categorical variables will be presented as 
frequencies and percentages. The baseline characteristics of the two groups will be compared 
using the chi-square test for categorical variables and the two-sample t-test for continuous 
variables. 
Primary outcome: 
For the patient-reported outcomes on pain understanding and communication, the mean scores 
from the Pain Communication and Understanding Questionnaire will be compared between the 
intervention (APE method) and control groups. A two-sample t-test will be used to analyze 
differences between the two groups. 
Secondary outcomes: 
Pain level will be measured using the VAS and assessed at baseline and at the two-week follow-
up. The two-week follow-up period was chosen to align with the expected initial response 
timeline for conservative TMD management, including NSAIDs, muscle relaxants, and 
behavioral modifications. A repeated-measures ANOVA will be conducted to evaluate changes 
in pain levels over time between the intervention and control groups. 
TMJ function will be measured by maximum mouth opening (MMO). Mean MMO scores will 
be compared between groups at baseline and follow-up using repeated-measures ANOVA to 
assess changes over time. 
Anxiety level will be measured using the General Anxiety Disorder-7 (GAD-7) questionnaire at 
baseline and the two-week follow-up. Mean GAD-7 scores will be compared between the 
intervention and control groups using repeated-measures ANOVA. 

Normality will be assessed for all outcomes. If deviations from normality are present, non-
parametric tests will be used. 
All analyses will be conducted using an intent-to-treat approach, and missing data will be 
handled through multiple imputation if appropriate. Statistical analyses will be performed using 
Stata/IC 18.0 (StataCorp LLC, College Station, TX, USA), and p-values ≤ 0.05 will be 
considered statistically significant. 
Handling of Missing Data: 
Multiple imputation used if missing data exceed 5%. All randomized participants will be 
included unless major protocol deviations occur. 
 
Ethical Considerations: 
Approved by the Research Ethics Committee of KAUFD (REC #02-01-25). Informed consent 
will be obtained from all participants. Confidentiality of participant data strictly maintained.