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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Beril Demir, Dr
- 電話番号：+905392622839
- メール：berilavci@gazi.edu.tr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
Standard verbal explanation about the procedure provided in the endoscopy unit as part of the usual informed consent process.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
State anxiety immediately before the procedure, measured by the Spielberger State-Trait Anxiety Inventory (state subscale, STAI-S)
時間枠：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.
|
Immediately before the procedure (within 30 minutes prior to sedation) on the day of ERCP
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure-related knowledge level immediately before the procedure
時間枠：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.
|
Immediately before the procedure on the day of ERCP
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-666
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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