Nurse-Led Education Before ERCP: Effects on Patient Knowledge and Anxiety (ERCP-EDU)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Beril Demir, Dr
- 전화번호: +905392622839
- 이메일: berilavci@gazi.edu.tr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current use of anxiolytic medication
- Known cognitive impairment or any condition preventing reliable completion of the questionnaires
- Need for emergency or urgent endoscopy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Structured nurse-led education
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.
|
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.
|
|
활성 비교기: Routine information
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.
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Standard verbal explanation about the procedure provided in the endoscopy unit as part of the usual informed consent process.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
State anxiety immediately before the procedure, measured by the Spielberger State-Trait Anxiety Inventory (state subscale, STAI-S)
기간: Immediately before the procedure (within 30 minutes prior to sedation) on the day of ERCP
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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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Procedure-related knowledge level immediately before the procedure
기간: Immediately before the procedure on the day of ERCP
|
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.
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Immediately before the procedure on the day of ERCP
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-666
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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