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Nurse-Led Education Before ERCP: Effects on Patient Knowledge and Anxiety

NCT07805577 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-09-04

No results posted yet for this study

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive procedure frequently accompanied by preprocedural anxiety, which has been associated with altered physiological parameters, reduced procedural tolerance, higher sedation requirements and lower patient satisfaction. Nurses are in a position to deliver structured preprocedural information and thereby strengthen patients' sense of control.

This randomized controlled trial will evaluate whether a structured, nurse-led, one-to-one educational intervention delivered before ERCP reduces state anxiety and improves procedure-related knowledge compared with routine institutional information. Sixty adult patients scheduled for ERCP will be randomly allocated to the intervention or control group. State anxiety will be assessed with the Spielberger State-Trait Anxiety Inventory (state subscale) and procedure-related knowledge with a 17-item multiple-choice questionnaire, both at baseline and immediately before the procedure.

Conditions

Interventions

BEHAVIORAL

Structured nurse-led preprocedural education

A standardized 30 to 45 minute one-to-one educational session delivered by a trained nurse using a slide presentation and a printed colour brochure, covering the purpose of ERCP, the sequence of events on the procedure day, sedation, expected sensations, procedure duration, the recovery period, postprocedural instructions and warning symptoms.

OTHER

Routine information

Standard verbal explanation about the procedure provided in the endoscopy unit as part of the usual informed consent process.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2026-12-31
Completion
2027-03-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805577 on ClinicalTrials.gov