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临床试验/NCT07732946
NCT07732946已完成不适用

Effect of ChatGPT-Assisted Pre-Procedural Education on Bowel Preparation Quality and Anxiety in First-Time Colonoscopy Patients: A Randomized Controlled Trial

Gazi University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2025年6月1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
190
试验地点
1
主要终点
Bowel preparation quality (Boston Bowel Preparation Scale, BBPS)

研究概览

简要总结

Background and rationale: Colonoscopy is central to colorectal cancer screening and prevention, but its diagnostic yield depends heavily on adequate bowel preparation; inadequate cleansing lowers adenoma detection and often necessitates repeat procedures. Pre-procedural anxiety is also common, particularly among patients undergoing colonoscopy for the first time. Conventional education is constrained by time and does not always address individual questions. Large language model-based tools such as ChatGPT can generate individualized, real-time responses and may serve as an adjunct to standard counseling.

Objective: To evaluate whether ChatGPT-assisted pre-procedural patient education, added to standard information, improves bowel preparation quality and reduces pre-procedural anxiety compared with standard information alone in patients undergoing their first colonoscopy.

Design and setting: Single-center, parallel-group, two-arm randomized controlled trial conducted in the Department of Gastroenterology, Gazi University Faculty of Medicine, Ankara, Türkiye. The study was approved by the Gazi University Clinical Research Ethics Committee (approval no. 2025-1016). Written informed consent was obtained from all participants.

Participants: Adults (aged ≥18 years) presenting for their first colonoscopy were eligible. [Buraya kalan dışlama kriterlerini ekle - ör. önceki kolonoskopi öyküsü, tablet kullanamama, ciddi bilişsel/işitsel engel vb.] Randomization and allocation: Eligible participants were randomly assigned in a 1:1 ratio to the standard-information (control) arm or the ChatGPT-assisted (intervention) arm, with allocation concealment.

Interventions:

Control arm: standard pre-procedural verbal and written bowel-preparation instructions per routine clinical practice.

Intervention arm: the same standard instructions plus supervised access to a ChatGPT interface (GPT-4o model, ChatGPT Plus) on a clinic-provided tablet before the procedure. Participants could ask questions in their preferred language, up to a maximum of ten. Chatbot responses were reviewed by the study team for clinical appropriateness.

Outcome measures:

Primary: (1) bowel preparation quality assessed with the Boston Bowel Preparation Scale (BBPS); (2) pre-procedural anxiety assessed with the State-Trait Anxiety Inventory (STAI).

Secondary: procedural tolerance (5-point Likert scale); adenoma detection rate; and completion of colonoscopy without sedation.

Sample size: Based on an a priori power analysis assuming a moderate effect size (Cohen's d ≈ 0.50) for the primary outcomes, with two-sided alpha of 0.05 and 80% power.

Statistical analysis: Outcomes were analyzed following the intention-to-treat principle. Between-group comparisons used t-test or Mann-Whitney U for continuous variables and chi-square/Fisher exact tests for categorical variables; multivariable logistic regression was used for binary outcomes.

详细描述

Colorectal cancer screening by colonoscopy is effective only when bowel preparation is adequate; inadequate cleansing reduces adenoma detection and often necessitates repeat procedures. Pre-procedural anxiety is common, particularly before a first colonoscopy. Routine counseling is frequently constrained by time and cannot always address each patient's individual questions. Large language model-based conversational tools such as ChatGPT (GPT-4o) can generate individualized, real-time responses and may complement standard physician-provided counseling.

This trial was designed to test that hypothesis in routine clinical practice. In the intervention arm, ChatGPT access was provided under supervision on a clinic-provided tablet immediately before the procedure, so that participants without a personal device or subscription could use it on equal terms. Participants asked their questions in their preferred language to reflect real-world use. All chatbot responses were reviewed by the study team for clinical appropriateness, and the tool was positioned as an adjunct to, rather than a replacement for, standard pre-procedural education.

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
Single (Outcomes Assessor)

盲法说明

Because the intervention involves patient interaction with a ChatGPT-based educational tool, participants and the staff delivering the intervention could not be masked. Bowel preparation was scored by an endoscopist who was blinded to group allocation. Self-reported anxiety (STAI) could not be masked by nature of the outcome.

入排标准

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

入选标准

  • Adults aged 18 years or older
  • Undergoing first (index) colonoscopy
  • Sufficient cognitive capacity to complete study questionnaires
  • Able to provide written informed consent

排除标准

  • History of prior colonoscopy
  • History of colorectal surgery
  • Known inflammatory bowel disease
  • Emergency colonoscopy
  • Severe comorbid conditions limiting cooperation
  • Unable to provide informed consent

研究组 & 干预措施

Standard Information (Control)

Active Comparator

Participants received standard pre-procedural verbal and written bowel-preparation instructions according to routine clinical practice, without access to the ChatGPT-based educational to

干预措施: Standard pre-procedural information (Behavioral)

ChatGPT-Assisted Education (Intervention)

Experimental

Participants received the same standard pre-procedural instructions plus supervised access to a ChatGPT interface (GPT-4o) on a clinic-provided tablet before the procedure, where they could ask questions in their preferred language (up to ten). Chatbot responses were reviewed by the study team for clinical appropriateness.

干预措施: ChatGPT-assisted pre-procedural patient education (Behavioral)

结局指标

主要结局

Bowel preparation quality (Boston Bowel Preparation Scale, BBPS)

时间窗: During colonoscopy (day of procedure)

Bowel cleansing quality assessed during colonoscopy using the Boston Bowel Preparation Scale, scored by endoscopists blinded to group allocation. Total score ranges from 0 to 9, with higher scores indicating better preparation.

次要结局

  • State anxiety (STAI-1)(On the day of colonoscopy, before the procedure)
  • Procedural tolerance(Immediately after colonoscopy (day of procedure))
  • Adenoma detection rate (ADR)(During colonoscopy (day of procedure))
  • Completion of colonoscopy without sedation(During colonoscopy (day of procedure))

研究者

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

Yunus Emre Börü

Research Assistant, Department of Gastroenterology

Gazi University

研究点 (1)

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