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

NCT07805577 | Not Yet Recruiting

• 1 other identifier: 2026-666
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Anxiety; Biliary Tract Diseases; Pancreatic Diseases

Keywords

ERCP; State-Trait Anxiety Inventory; Nursing education; Endoscopy; Patient education; Preprocedural anxiety; Knowledge level

Outcome Measures

Primary Outcomes (1)

• State anxiety immediately before the procedure, measured by the Spielberger State-Trait Anxiety Inventory (state subscale, STAI-S)

  The state subscale of the Spielberger State-Trait Anxiety Inventory comprises 20 items scored on a four-point scale, yielding a total score between 20 and 80, with higher scores indicating greater anxiety. The assessment is performed after delivery of the allocated intervention and before administration of any sedative agent.

  Immediately before the procedure (within 30 minutes prior to sedation) on the day of ERCP

Secondary Outcomes (1)

• Procedure-related knowledge level immediately before the procedure

  Immediately before the procedure on the day of ERCP

Study Arms (2)

Structured nurse-led education

EXPERIMENTAL

Participants receive routine institutional information plus a structured one-to-one educational session delivered by a trained nurse (standardized slide presentation and printed colour brochure), lasting approximately 30 to 45 minutes, before the procedure.

Behavioral: Structured nurse-led preprocedural education

Routine information

ACTIVE COMPARATOR

Participants receive the routine information ordinarily provided in the endoscopy unit before ERCP, consisting of the standard verbal explanation given during the informed consent process.

Other: Routine information

Interventions

Routine information OTHER

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

Routine information

Structured nurse-led preprocedural education BEHAVIORAL

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.

Structured nurse-led education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Scheduled to undergo elective ERCP
• Able to read and understand Turkish
• Willing to participate and able to provide written informed consent

You may not qualify if:

• Current use of anxiolytic medication
• Known cognitive impairment or any condition preventing reliable completion of the questionnaires
• Need for emergency or urgent endoscopy

Sponsors & Collaborators

• Gazi University: lead

MeSH Terms

Conditions

Anxiety Disorders; Biliary Tract Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Digestive System Diseases

Central Study Contacts

Beril Demir, Dr

CONTACT

+905392622839; berilavci@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share