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

31 luglio 2026 aggiornato da: Yunus Emre Börü, Gazi University

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

190

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Yenimahalle
      • Ankara, Yenimahalle, Turchia (Türkiye), 06560
        • Gazi University Faculty of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Participants received standard pre-procedural verbal and written bowel-preparation instructions according to routine clinical practice, without access to the ChatGPT-based educational tool.
Sperimentale: 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.
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bowel preparation quality (Boston Bowel Preparation Scale, BBPS)
Lasso di tempo: 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.
During colonoscopy (day of procedure)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
State anxiety (STAI-1)
Lasso di tempo: On the day of colonoscopy, before the procedure
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.
On the day of colonoscopy, before the procedure
Procedural tolerance
Lasso di tempo: Immediately after colonoscopy (day of procedure)
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.
Immediately after colonoscopy (day of procedure)
Adenoma detection rate (ADR)
Lasso di tempo: During colonoscopy (day of procedure)
Proportion of patients in whom at least one adenoma was detected among those who completed colonoscopy.
During colonoscopy (day of procedure)
Completion of colonoscopy without sedation
Lasso di tempo: During colonoscopy (day of procedure)
Proportion of patients who completed colonoscopy without the use of sedation.
During colonoscopy (day of procedure)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2025

Completamento primario (Effettivo)

31 dicembre 2025

Completamento dello studio (Effettivo)

1 marzo 2026

Date di iscrizione allo studio

Primo inviato

22 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2026

Primo Inserito (Effettivo)

29 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-1016

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data are available from the corresponding author upon reasonable request.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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