- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07732946
Effect of ChatGPT-Assisted Pre-Procedural Education on Bowel Preparation Quality and Anxiety in First-Time Colonoscopy Patients
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.
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.
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Yenimahalle
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Ankara, Yenimahalle, Törökország (Türkiye), 06560
- Gazi University Faculty of Medicine
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Adults aged 18 years or older
- Undergoing first (index) colonoscopy
- Sufficient cognitive capacity to complete study questionnaires
- Able to provide written informed consent
Exclusion Criteria:
- History of prior colonoscopy
- History of colorectal surgery
- Known inflammatory bowel disease
- Emergency colonoscopy
- Severe comorbid conditions limiting cooperation
- Unable to provide informed consent
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: Standard Information (Control)
Participants received standard pre-procedural verbal and written bowel-preparation instructions according to routine clinical practice, without access to the ChatGPT-based educational to
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Participants received standard pre-procedural verbal and written bowel-preparation instructions according to routine clinical practice, without access to the ChatGPT-based educational tool.
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Kísérleti: ChatGPT-Assisted Education (Intervention)
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.
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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
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Bowel preparation quality (Boston Bowel Preparation Scale, BBPS)
Időkeret: During colonoscopy (day of procedure)
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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.
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During colonoscopy (day of procedure)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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State anxiety (STAI-1)
Időkeret: On the day of colonoscopy, before the procedure
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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.
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On the day of colonoscopy, before the procedure
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Procedural tolerance
Időkeret: Immediately after colonoscopy (day of procedure)
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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.
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Immediately after colonoscopy (day of procedure)
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Adenoma detection rate (ADR)
Időkeret: During colonoscopy (day of procedure)
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Proportion of patients in whom at least one adenoma was detected among those who completed colonoscopy.
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During colonoscopy (day of procedure)
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Completion of colonoscopy without sedation
Időkeret: During colonoscopy (day of procedure)
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Proportion of patients who completed colonoscopy without the use of sedation.
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During colonoscopy (day of procedure)
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2025-1016
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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