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

31. juli 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

190

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bowel preparation quality (Boston Bowel Preparation Scale, BBPS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
State anxiety (STAI-1)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: During colonoscopy (day of procedure)
Proportion of patients who completed colonoscopy without the use of sedation.
During colonoscopy (day of procedure)

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Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2025

Primær fullføring (Faktiske)

31. desember 2025

Studiet fullført (Faktiske)

1. mars 2026

Datoer for studieregistrering

Først innsendt

22. juli 2026

Først innsendt som oppfylte QC-kriteriene

27. juli 2026

Først lagt ut (Faktiske)

29. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-1016

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

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