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临床试验/NCT07698847
NCT07698847已完成不适用

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

Cukurova University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in Patient Knowledge Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Standardized Verbal Education

Active Comparator

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.

干预措施: Standardized Verbal Education (Behavioral)

Leaflet-Based Education

Experimental

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.

干预措施: Leaflet-Based Education (Behavioral)

Video-Based Education

Experimental

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.

干预措施: Video-Based Education (Behavioral)

结局指标

主要结局

Change in Patient Knowledge Score

时间窗: 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.

Change in Antibiotic Misconception Score

时间窗: 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.

Change in Anxiety Level

时间窗: Immediately before the educational intervention and immediately after the educational intervention on the same day

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.

次要结局

  • Teach-Back Critical Elements Score(Immediately after the educational intervention on the same day)
  • Teach-Back Global Adequacy Rating(Immediately after the educational intervention on the same day)
  • Generability of the AI-Assisted Complaint Summary(During the same clinical visit, after collection of standardized symptom information)
  • Completeness of the AI-Assisted Complaint Summary(Immediately after generation of the AI-assisted complaint summary during the same clinical visit)
  • Clinician-Rated Usefulness of the AI-Assisted Complaint Summary(Immediately after review of the AI-assisted complaint summary during the same clinical visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Gürler

Principal Investigator

Cukurova University

研究点 (1)

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