Nurse-Led Education Before ERCP: Effects on Patient Knowledge and Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGazi University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Current use of anxiolytic medication
Known cognitive impairment or any condition preventing reliable completion of the questionnaires
Need for emergency or urgent endoscopy
Trial design
Design model
Parallel
Treatments tested in this trial
Structured nurse-led preprocedural education
BehavioralA 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.
Routine information
Other interventionStandard verbal explanation about the procedure provided in the endoscopy unit as part of the usual informed consent process.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Structured nurse-led educationExperimental treatment 1 intervention
Group B: Routine informationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Immediately before the procedure (within 30 minutes prior to sedation) on the day of ERCPSecondary outcomes
1
Procedure-related knowledge level immediately before the procedure
Knowledge about ERCP is assessed with a 17-item multiple-choice questionnaire developed by the investigators, with one point awarded for each correct answer, producing a total score between 0 and 17, where higher scores indicate greater knowledge.
Time frame
Immediately before the procedure on the day of ERCPLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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