Patient Adherence to Splint Therapy and Counseling Programs in Temporomandibular Disorders: Development and Validation of a New Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Content Validity of the Adherence Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Content Validity of the Adherence Questionnaire
时间窗: 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
时间窗: 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
次要结局
- Construct Validity via Exploratory Factor Analysis (EFA)(Baseline (after 6 months of treatment))
- Test-Retest Reliability of the Adherence Questionnaire(1-week interval after baseline administration)
研究者
Soaad Tolba Mohammed Tolba Badawi
Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Egypt
Mansoura University