Behavioral Counseling, Splint Therapy, Temporomandibular Disorders (TMDs), Treatment Adherence and Compliance
Conditions
Keywords
Temporomandibular joint disorder, TMD adherence, Splint compliance, Counseling adherence, Psychometric validation, Questionnaire development, Conservative TMD treatment
Brief summary
The goal of this observational study is to assess patient adherence to splint therapy and behavioral counseling among individuals diagnosed with TMDs. The study uses a newly developed bilingual (Arabic and English) questionnaire to evaluate adherence behaviors. The main question it aims to answer is: How consistently do TMDs patients follow conservative treatment protocols, including splint use and counseling recommendations? Participants who are already receiving splint therapy and counseling as part of their standard care will complete the questionnaire to help researchers validate the tool and understand adherence patterns. Last updated on June 20, 2025.
Detailed description
This observational study aims to validate a newly developed adherence questionnaire tailored to measure patient compliance with conservative treatment protocols of TMDs, including splint therapy and behavioral counseling. The questionnaire was developed in both Arabic and English and underwent content validation, pilot testing, and psychometric evaluation. Participants included in the study are individuals already undergoing treatment for TMD, specifically splint therapy and counseling, as part of their standard clinical care. The study does not assign any interventions but focuses on collecting data through patient-reported responses to the adherence questionnaire. Data collected will be used to assess the questionnaire's reliability, validity, and factor structure to establish it as a robust tool for clinical and research settings. The outcomes of this study are expected to support the identification of non-adherent patients and facilitate targeted interventions to enhance treatment outcomes.
Interventions
OTHERConservative Management for TMD
This intervention includes a standardized conservative treatment protocol for TMDs, comprising splint therapy and a structured counseling program. The counseling covers education on diagnosis, medication adherence, dietary modifications, posture and behavior correction, sleep hygiene, parafunctional habit avoidance, physiotherapy exercises, pain and stress management, and importance of follow-up visits. Patients receive individualized instructions and monitoring as part of their routine clinical care. Adherence to these components is measured after 6 months of treatment using a validated adherence questionnaire.
Sponsors
Soaad Tolba Mohammed Tolba Badawi
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older * Diagnosed with TMDs based on DC/TMD criteria * Completed at least 6 months of conservative treatment (e.g., splint therapy and counseling program) * Able to read and understand Arabic or English * Provided informed consent
Exclusion criteria
* History of Temporomandibular joint (TMJ) surgery * Currently undergoing other TMD-related treatments * Presence of systemic musculoskeletal disorders (e.g., fibromyalgia, rheumatoid arthritis) * Cognitive or psychiatric disorders impairing ability to participate * Incomplete treatment duration (less than 6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Content Validity of the Adherence Questionnaire | Preceding patient data collection (before pilot phase) | Assessment of content validity using expert panel ratings to compute Item Content Validity Index (I-CVI) and Content Validity Ratio (CVR). Unit of Measure: I-CVI and CVR values |
| Internal Consistency of the Adherence Questionnaire | Baseline (after 6 months of treatment) | Evaluation of the internal consistency of the items of adherence questionnaire using Cronbach's alpha across all domains and total score. Unit of Measure: Cronbach's alpha coefficient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test-Retest Reliability of the Adherence Questionnaire | 1-week interval after baseline administration | Assessment of temporal stability using Intraclass Correlation Coefficient (ICC) between two administrations of the questionnaire, 1 week apart. Unit of Measure: ICC |
| Construct Validity via Exploratory Factor Analysis (EFA) | Baseline (after 6 months of treatment) | Evaluation of construct validity through Exploratory Factor Analysis to identify the underlying factor structure. Unit of Measure: Number of factors extracted and percent variance explained |
Countries
Egypt
Outcome results
None listed