AnxietyERCP-EDUNCT07805577
Nurse-Led Education Before ERCP: Effects on Patient Knowledge and Anxiety
A study testing Structured nurse-led preprocedural education and Routine information in people with Anxiety and Biliary Tract Diseases, run by Gazi University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Biliary Tract Diseases, Pancreatic Diseases
- What is being tested?
- Structured nurse-led preprocedural education and Routine information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current use of anxiolytic medication
- Known cognitive impairment or any condition preventing reliable completion of the questionnaires
- Need for emergency or urgent endoscopy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Structured Nurse-Led Preprocedural Education on Knowledge Level and State Anxiety in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled 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.
Read the detailed description
Setting. The study will be conducted in the Endoscopy Unit of the Department of Gastroenterology, Gazi University Faculty of Medicine.
Participants and allocation. Adults aged 18 years or older scheduled for elective ERCP who are able to read and understand Turkish and who provide written informed consent will be enrolled. Participants will be randomly allocated in a 1:1 ratio to the intervention or control group using a computer-generated randomization sequence with sequentially numbered, opaque, sealed envelopes for allocation concealment.
Control group. Patients will receive the routine information ordinarily provided in the unit before ERCP, consisting of the standard verbal explanation given during the informed consent process.
Intervention group. In addition to routine information, patients will receive a structured, one-to-one educational session delivered by a trained nurse. The session lasts approximately 30 to 45 minutes and comprises a standardized slide presentation and a printed colour brochure covering the purpose of ERCP, the sequence of events on the procedure day, sedation, expected sensations, duration, the recovery period, postprocedural instructions and warning symptoms.
Assessments. A structured interview form will record demographic and clinical characteristics. The state subscale of the Spielberger State-Trait Anxiety Inventory and a 17-item multiple-choice knowledge questionnaire will be administered at baseline (before allocation) and immediately before the procedure, after the intervention has been delivered and before any sedative agent is given. A further state anxiety assessment will be performed two hours after the end of the procedure.
Blinding. Because of the nature of the intervention, participants and the nurse delivering the education cannot be blinded. The investigator performing data entry and statistical analysis will be blinded to group allocation.
Statistical analysis. Data will be analysed with SPSS version 26.0. Distribution will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons of continuous variables will use the independent samples t test or the Mann-Whitney U test as appropriate, and within-group comparisons will use the paired t test or the Wilcoxon signed rank test. Categorical variables will be compared using the chi-square test or Fisher exact test. Analysis of covariance will be used to compare postintervention scores with adjustment for baseline values. A two-sided p value below 0.05 will be considered statistically significant.
- Conditions
- Anxiety, Biliary Tract Diseases, Pancreatic Diseases
- Being tested
- Structured nurse-led preprocedural education, Routine information
- Keywords
- ERCP, State-Trait Anxiety Inventory, Nursing education, Endoscopy, Patient education, Preprocedural anxiety, Knowledge level
- Medical subject headings
- Anxiety Disorders, Biliary Tract Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured nurse-led preprocedural educationBehavioural
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.
Routine informationOther
Standard verbal explanation about the procedure provided in the endoscopy unit as part of the usual informed consent process.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Immediately before the procedure on the day of ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beril DEMIR, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805577
- Sponsor's protocol ID
- 2026-666
- Acronym
- ERCP-EDU
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified data may be made available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Nurse-Led Preprocedural Education on Knowledge Level and State Anxiety in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07805577
- Acronym / sponsor ID
- ERCP-EDU / 2026-666
- Conditions
- Anxiety, Biliary Tract Diseases, Pancreatic Diseases
- Keywords
- ERCP, State-Trait Anxiety Inventory, Nursing education, Endoscopy, Patient education, Preprocedural anxiety, Knowledge level
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Setting. The study will be conducted in the Endoscopy Unit of the Department of Gastroenterology, Gazi University Faculty of Medicine.
Participants and allocation. Adults aged 18 years or older scheduled for elective ERCP who are able to read and understand Turkish and who provide written informed consent will be enrolled. Participants will be randomly allocated in a 1:1 ratio to the intervention or control group using a computer-generated randomization sequence with sequentially numbered, opaque, sealed envelopes for allocation concealment.
Control group. Patients will receive the routine information ordinarily provided in the unit before ERCP, consisting of the standard verbal explanation given during the informed consent process.
Intervention group. In addition to routine information, patients will receive a structured, one-to-one educational session delivered by a trained nurse. The session lasts approximately 30 to 45 minutes and comprises a standardized slide presentation and a printed colour brochure covering the purpose of ERCP, the sequence of events on the procedure day, sedation, expected sensations, duration, the recovery period, postprocedural instructions and warning symptoms.
Assessments. A structured interview form will record demographic and clinical characteristics. The state subscale of the Spielberger State-Trait Anxiety Inventory and a 17-item multiple-choice knowledge questionnaire will be administered at baseline (before allocation) and immediately before the procedure, after the intervention has been delivered and before any sedative agent is given. A further state anxiety assessment will be performed two hours after the end of the procedure.
Blinding. Because of the nature of the intervention, participants and the nurse delivering the education cannot be blinded. The investigator performing data entry and statistical analysis will be blinded to group allocation.
Statistical analysis. Data will be analysed with SPSS version 26.0. Distribution will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons of continuous variables will use the independent samples t test or the Mann-Whitney U test as appropriate, and within-group comparisons will use the paired t test or the Wilcoxon signed rank test. Categorical variables will be compared using the chi-square test or Fisher exact test. Analysis of covariance will be used to compare postintervention scores with adjustment for baseline values. A two-sided p value below 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured nurse-led education | Experimental | Behavioral: Structured nurse-led preprocedural educationParticipants 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. |
| Routine information | Active comparator | Other: Routine informationParticipants receive the routine information ordinarily provided in the endoscopy unit before ERCP, consisting of the standard verbal explanation given during the informed consent process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current use of anxiolytic medication
- Known cognitive impairment or any condition preventing reliable completion of the questionnaires
- Need for emergency or urgent endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured nurse-led preprocedural educationA 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. | Behavioural | Structured nurse-led education |
| Routine informationStandard verbal explanation about the procedure provided in the endoscopy unit as part of the usual informed consent process. | Other | Routine information |
Primary outcome
State anxiety immediately before the procedure, measured by the Spielberger State-Trait Anxiety Inventory (state subscale, STAI-S)
Time frame: Immediately before the procedure (within 30 minutes prior to sedation) on the day of ERCP
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.
1 secondary outcome
Procedure-related knowledge level immediately before the procedure
Time frame: Immediately before the procedure on the day of ERCP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified data may be made available from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Structured nurse-led preprocedural education and Routine information in people with Anxiety and Biliary Tract Diseases, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beril Demir, Dr (+905392622839, berilavci@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety immediately before the procedure, measured by the Spielberger State-Trait Anxiety Inventory (state subscale, STAI-S) (time frame: Immediately before the procedure (within 30 minutes prior to sedation) on the day of ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.