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临床试验/NCT07019688
NCT07019688已完成不适用

Evaluation of Anxiety During Impacted Molar Extraction: The Influence of Verbal, Traditional, and AI-Generated Information Methods on Anesthesia Management

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年6月16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
发起方
入组人数
105
试验地点
1
主要终点
Change in Dental Anxiety Level

研究概览

简要总结

The aim of this clinical study is to investigate the effects of different information methods on patients' anxiety levels during dental procedures under anesthesia. Additionally, the study seeks to evaluate patients' concerns and willingness regarding dental treatment under anesthesia, as well as their awareness of the associated risks.

The main questions this study aims to answer are:

  • How do various information methods influence patients' anxiety levels related to dental procedures under anesthesia?
  • What is the relationship between patients' anxiety levels and their awareness of risks associated with dental treatment under anesthesia?

The study hypothesizes that different information methods may vary in their effectiveness at reducing patient stress, and that patients' anxiety levels regarding dental treatment under anesthesia may be associated with their knowledge about potential risks.

详细描述

In this study, questions from 25 patients scheduled for molar tooth extraction will first be collected, and the 20 most frequently asked questions will be identified. The answers to these questions will then be incorporated into routine information procedures. Researchers will prepare verbal, standard written, and written informative materials addressing these questions. To evaluate the impact of artificial intelligence, the identified questions will be submitted to ChatGPT, and the AI-generated responses will be used to create an informational form.

Following the identification of frequently asked questions, newly enrolled patients will be randomly assigned into three groups. Group 1 will receive standard written information, Group 2 will receive clinician-prepared written information containing answers to the identified questions, and Group 3 will receive a written informational form prepared by ChatGPT based on the identified questions. Each group will comprise 35 patients.

Prior to receiving information, participants will complete a baseline survey. Patients will be assigned unique codes, and data including age, gender, educational status, Modified Dental Anxiety Scale (MDAS) scores, and anxiety levels related to dental procedures and anesthesia will be collected. Patients will then receive group-specific information. A follow-up appointment will be scheduled one week later. At this visit, anxiety levels will be reassessed using the MDAS, and additional information will be collected regarding sources consulted for supplementary information (e.g., social media, websites, patient testimonials) and patients' knowledge of anesthesia-related complications. Patients with an MDAS score below 19 will undergo molar tooth extraction under local anesthesia. Those with an MDAS score of 19 or higher will be referred to the anesthesiology faculty member, who also serves as the principal investigator of this study, for the necessary procedures related to dental treatment under anesthesia.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Indication for moderately difficult, non-complicated impacted mandibular molar extraction
  • •Aged 18-40 years
  • •No systemic disease or regular medication use
  • •No previous procedures under sedation or general anesthesia
  • •No history of impacted molar surgery or complicated extractions
  • •No prior verbal, written, or visual information on molar extractions

排除标准

  • •Complex or multiple (>2) molar extractions
  • •Intellectual disability
  • •Emergency cases
  • •Refusal to participate or to receive preoperative information

研究组 & 干预措施

Group 1: Standard Info

Participants receive the standard written information routinely provided before molar tooth extraction.

干预措施: Standard Information (Other)

Group 2: Clinician Info

Participants receive written information prepared by clinicians that includes answers to the most frequently asked questions from previous patients.

干预措施: Clinician Information (Other)

Group 3: AI Info

Participants receive written information generated by ChatGPT based on the identified frequently asked questions.

干预措施: AI Info (Other)

结局指标

主要结局

Change in Dental Anxiety Level

时间窗: Baseline (pre-information) and 1 week post-information

Change in anxiety levels measured using the Modified Dental Anxiety Scale (MDAS) before and one week after the informational intervention. The primary comparison will assess differences between the three groups receiving different information methods.

次要结局

未报告次要终点

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gözde Nur Erkan

Assistant Professor, Department of Oral and Maxillofacial Surgery

Kırıkkale University

研究点 (1)

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