ColonoscopyNCT07732946
Effect of ChatGPT-Assisted Pre-Procedural Education on Bowel Preparation Quality and Anxiety in First-Time Colonoscopy Patients
A study testing ChatGPT-assisted pre-procedural patient education and Standard pre-procedural information in people with Colonoscopy and Bowel Preparation Quality, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Preparation Quality, Preoperative Anxiety
- What is being tested?
- ChatGPT-assisted pre-procedural patient education and Standard pre-procedural information
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Undergoing first (index) colonoscopy
- Sufficient cognitive capacity to complete study questionnaires
- Able to provide written informed consent
Who cannot join
- History of prior colonoscopy
- History of colorectal surgery
- Known inflammatory bowel disease
- Emergency colonoscopy
- Severe comorbid conditions limiting cooperation
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine
Ankara, Yenimahalle, 06560
About this study
Official title: Effect of ChatGPT-Assisted Pre-Procedural Education on Bowel Preparation Quality and Anxiety in First-Time Colonoscopy Patients: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Being tested
- ChatGPT-assisted pre-procedural patient education, Standard pre-procedural information
- Keywords
- ChatGPT, Patient education, Bowel preparation, Anxiety, Colonoscopy, Artificial intelligence
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPT-assisted pre-procedural patient educationBehavioural
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
Standard pre-procedural informationBehavioural
Participants received standard pre-procedural verbal and written bowel-preparation instructions according to routine clinical practice, without access to the ChatGPT-based educational tool.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: ChatGPT-assisted pre-procedural patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During colonoscopy (day of procedure)
Secondary outcomes (4)
State anxiety (STAI-1)
Situational anxiety assessed with the State subscale of the State-Trait Anxiety Inventory (STAI-1) on the day of the procedure. Scores range from 20 to 80, with higher scores indicating greater anxiety.
Measured: On the day of colonoscopy, before the procedure
Procedural tolerance
Patient-reported tolerance of the colonoscopy procedure, rated on a 5-point Likert scale ranging from 1 (very poor tolerance) to 5 (excellent tolerance). Higher scores indicate better tolerance.e.
Measured: Immediately after colonoscopy (day of procedure)
Adenoma detection rate (ADR)
Proportion of patients in whom at least one adenoma was detected among those who completed colonoscopy.
Measured: During colonoscopy (day of procedure)
Completion of colonoscopy without sedation
Proportion of patients who completed colonoscopy without the use of sedation.
Measured: During colonoscopy (day of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Börü, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732946
- Sponsor's protocol ID
- 2025-1016
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are available from the corresponding author upon reasonable request.