Patient Education and AI-Assisted Complaint Summaries in Endodontic Patients
7 de julio de 2026 actualizado por: Kübra Gürler, Cukurova University
The Effect of Different Patient Education Methods in Patients Presenting to an Endodontic Clinic With Toothache and the Feasibility of an AI-Assisted Complaint Summary
The goal of this randomized clinical trial is to compare the same-day effects of three standardized patient education methods in adults presenting to an endodontic clinic with toothache.
The main questions it aims to answer are:
- Does standardized verbal education improve patients' knowledge, reduce antibiotic-related misconceptions, and reduce anxiety?
- Does leaflet-based education produce comparable changes in knowledge, antibiotic-related misconceptions, and anxiety?
- Does video-based education produce comparable changes in knowledge, antibiotic-related misconceptions, and anxiety?
- Does teach-back performance differ according to the method used to deliver patient education?
- Can an AI-assisted three-sentence complaint summary be generated reliably and used as a feasible clinician-facing communication support tool?
Participants will be randomly assigned to one of three patient education groups.
In the verbal education group, participants will receive a standardized 90-second verbal explanation covering warning signs, appropriate home-care measures, avoidance of potentially harmful practices, and appropriate antibiotic use.
In the leaflet-based education group, participants will review a written leaflet containing the same core educational messages for 90 seconds.
In the video-based education group, participants will watch a short video presenting the same core educational messages for 90 seconds.
Knowledge level, antibiotic-related misconceptions, and anxiety will be assessed immediately before and immediately after the educational intervention. After education, participants will also be asked to restate the main messages in their own words using a teach-back procedure.
In addition, symptom information collected using standardized prompts will be entered into an artificial intelligence tool to generate a concise three-sentence complaint summary. The feasibility, completeness, and clinician-rated usefulness of these summaries will be evaluated as process outcomes. AI-generated summaries will not be used for diagnosis, triage, or treatment decisions.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Sarıçam
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Adana, Sarıçam, Turquía (Türkiye), 01250
- Cukurova University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Reported pain of at least 1 point on a 0-10 numeric rating scale (NRS ≥ 1) at presentation,
- Were aged 18-65 years,
- Had sufficient cognitive capacity to complete the questionnaires, and
- Provided written informed consent.
Exclusion Criteria:
- Reported no pain at presentation (NRS = 0) or presented electively/asymptomatically,
- Required immediate emergency clinical evaluation due to signs suggestive of urgent intervention (e.g., marked diffuse swelling, dysphagia, dyspnea),
- Had substantial communication or cognitive difficulties preventing completion of the measures, or
- Were repeat participants (i.e., the same patient re-entering the study).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Standardized Verbal Education
Participants received a standardized 90-second verbal education session immediately after baseline assessment.
The education covered warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and the appropriate use of antibiotics for dental pain.
The content and sequence were delivered using a standardized script.
|
Participants received a standardized 90-second verbal education session immediately after baseline assessment.
The education included warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and guidance on the appropriate use of antibiotics for dental pain.
A standardized script was used to ensure consistency of content and sequence.
|
|
Experimental: Leaflet-Based Education
Participants reviewed a written educational leaflet for 90 seconds immediately after baseline assessment.
The leaflet contained the same core messages as the verbal education, including warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and the appropriate use of antibiotics for dental pain.
|
Participants reviewed a written educational leaflet for 90 seconds immediately after baseline assessment.
The leaflet included warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and guidance on the appropriate use of antibiotics for dental pain.
The educational content was equivalent to that provided in the verbal and video groups.
|
|
Experimental: Video-Based Education
Participants watched a 90-second educational video immediately after baseline assessment.
The video presented the same core messages as the verbal and leaflet-based education, including warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and the appropriate use of antibiotics for dental pain.
|
Participants watched a 90-second educational video immediately after baseline assessment.
The video included warning signs requiring urgent dental care, appropriate home-care measures, avoidance of potentially harmful practices, and guidance on the appropriate use of antibiotics for dental pain.
The educational content was equivalent to that provided in the verbal and leaflet-based education groups.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Patient Knowledge Score
Periodo de tiempo: Immediately before the educational intervention and immediately after the educational intervention on the same day
|
Patient knowledge will be assessed using an 8-item questionnaire developed according to the standardized educational content.
Each item will be scored as 1 for a correct response and 0 for an incorrect or unsure response, yielding a total score ranging from 0 to 8. Higher scores indicate greater knowledge.
The change score will be calculated as the post-education score minus the baseline score (T1 - T0) and compared among the verbal, leaflet-based, and video-based education groups.
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Immediately before the educational intervention and immediately after the educational intervention on the same day
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Change in Antibiotic Misconception Score
Periodo de tiempo: Immediately before the educational intervention and immediately after the educational intervention on the same day
|
Antibiotic-related misconceptions will be assessed using a 5-item Likert-type scale.
Each item will be rated from 1 to 5, yielding a total score ranging from 5 to 25.
Higher scores indicate stronger endorsement of antibiotic-related misconceptions.
The change score will be calculated as the post-education score minus the baseline score (T1 - T0) and compared among the three education groups.
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Immediately before the educational intervention and immediately after the educational intervention on the same day
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Change in Anxiety Level
Periodo de tiempo: Immediately before the educational intervention and immediately after the educational intervention on the same day
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Anxiety related to the presenting dental pain will be assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates no anxiety and 10 indicates the worst imaginable anxiety.
The change score will be calculated as the post-education score minus the baseline score (T1 - T0) and compared among the verbal, leaflet-based, and video-based education groups.
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Immediately before the educational intervention and immediately after the educational intervention on the same day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Teach-Back Critical Elements Score
Periodo de tiempo: Immediately after the educational intervention on the same day
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Immediately after the educational intervention, participants will be asked to restate the main educational messages in their own words within approximately 20-30 seconds.
Teach-back performance will be evaluated using five predefined critical elements.
Each element will be scored as present or absent, yielding a total score ranging from 0 to 5. Higher scores indicate more complete recall of the educational content.
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Immediately after the educational intervention on the same day
|
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Teach-Back Global Adequacy Rating
Periodo de tiempo: Immediately after the educational intervention on the same day
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The overall adequacy of the participant's teach-back response will be rated on a 3-point scale ranging from 0 to 2. A score of 0 indicates an incorrect, unsafe, or markedly incomplete response; a score of 1 indicates a partially correct response with missing critical elements; and a score of 2 indicates a correct and adequate response.
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Immediately after the educational intervention on the same day
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Generability of the AI-Assisted Complaint Summary
Periodo de tiempo: During the same clinical visit, after collection of standardized symptom information
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The ability to generate a concise three-sentence AI-assisted complaint summary from standardized, de-identified symptom information will be recorded as generated or not generated.
The proportion of successfully generated summaries will be calculated for all participants.
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During the same clinical visit, after collection of standardized symptom information
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Completeness of the AI-Assisted Complaint Summary
Periodo de tiempo: Immediately after generation of the AI-assisted complaint summary during the same clinical visit
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The completeness of each AI-assisted complaint summary will be assessed according to the presence of five predefined symptom-related components.
The completeness score will range from 0 to 5, with higher scores indicating more complete coverage of the required information.
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Immediately after generation of the AI-assisted complaint summary during the same clinical visit
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Clinician-Rated Usefulness of the AI-Assisted Complaint Summary
Periodo de tiempo: Immediately after review of the AI-assisted complaint summary during the same clinical visit
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The usefulness of the AI-assisted complaint summary for structuring the clinical encounter will be rated by a single endodontist on a numeric rating scale ranging from 0 to 10, where 0 indicates not useful at all and 10 indicates extremely useful.
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Immediately after review of the AI-assisted complaint summary during the same clinical visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de diciembre de 2025
Finalización primaria (Actual)
12 de marzo de 2026
Finalización del estudio (Actual)
24 de abril de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13.03.2026/104
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .