Effect of ChatGPT-Assisted Pre-Procedural Education on Bowel Preparation Quality and Anxiety in First-Time Colonoscopy Patients

NCT07732946 | Completed

• 1 other identifier: 2025-1016
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy; Bowel Preparation Quality; Preoperative Anxiety; Patient Education

Keywords

ChatGPT; Patient education; Bowel preparation; Anxiety; Colonoscopy; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Bowel preparation quality (Boston Bowel Preparation Scale, BBPS)

  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.

  During colonoscopy (day of procedure)

Secondary Outcomes (4)

• 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)

Study Arms (2)

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

Behavioral: Standard pre-procedural information

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.

Behavioral: ChatGPT-assisted pre-procedural patient education

Interventions

ChatGPT-assisted pre-procedural patient education BEHAVIORAL

Participants in the intervention arm received the standard pre-procedural bowel-preparation instructions plus supervised access to a ChatGPT-based educational tool (GPT-4o model, ChatGPT Plus) on a clinic-provided tablet before colonoscopy. Participants could ask questions about the procedure and bowel preparation in their preferred language, up to a maximum of ten questions. All chatbot responses were reviewed by the study team for clinical appropriateness. The tool was provided as an adjunct to, not a replacement for, standard physician-provided educatio

ChatGPT-Assisted Education (Intervention)

Standard pre-procedural information BEHAVIORAL

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

Standard Information (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yunus Emre Börü: lead

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)