Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy
2026年8月7日 更新者：Maja Arđelan、University of Mostar
Impact of Structured Periprocedural Nursing Interventions on Resilience and Anxiety in Men Undergoing Transrectal Prostate Biopsy: A Prospective Longitudinal Interventions Study With Histopathological Stratification
This prospective longitudinal interventional study aims to evaluate the effect of structured peri-procedural nursing interventions on resilience and anxiety in men undergoing transrectal prostate biopsy.
Participants will receive a standardized nursing intervention before and after the biopsy procedure.
Resilience, anxiety, pain, lower urinary tract symptoms, and perceived nursing support will be assessed at predefined time points.
Histopathological findings (benign or malignant) will be used for subgroup analyses.
The study is conducted at the University Clinical Hospital Mostar, Bosnia and Herzegovina.
研究概览
详细说明
This is a prospective, single-center, longitudinal interventional study conducted at the Department of Urology, University Clinical Hospital Mostar, Bosnia and Herzegovina.
The objective is to determine whether structured peri-procedural nursing interventions improve resilience and reduce anxiety in men undergoing transrectal prostate biopsy.
Participants will be assessed at three time points:
- baseline before the biopsy,
- 0-24 Houra after the procedure
- 2-3 weeks after the biopsy after receiving histopathological results. The study outcomes include resilience, anxiety, pain, lower urinary tract symptoms, and patients perception of nursing support.
Histopathological disgnosis (benign or malignant) will be used for subgroup analyses.
Approximately 120-140 participants are expected to be enrolled, with an anticipated final sample of approximately 100-110 participants after follow-up.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Maja Ardjelan, MSc
- 电话号码：00387 36 336 162
- 邮箱：majaardjelan555@gmail.com
学习地点
-
-
Federation of Bosnia and Herzegovina
-
Mostar、Federation of Bosnia and Herzegovina、波斯尼亚和黑塞哥维那、88000
- 招聘中
- University Clinical Hospital Mostar
-
接触：
- Maja Ardjelan, MSc
- 电话号码：00387 36 336 162
- 邮箱：majaardjelan555@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Male participants aged 40 years or older.
- Scheduled for transrectal ultrasound-guided prostate biopsy because of suspected prostate cancer.
- Able to understand the study procedures and provide written informed consent.
- Willing to complete all study assessments during the follow-up period.
Exclusion Criteria:
- Inabillity to provide informed consent.
- Severe cognitive impairment or psychiatric disorder preventing questionnaire completion.
- Previous disgnosis of prostate cancer.
- Inabillity to complete follow-up assessments.
- Withdrawal of informed consent at any time.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Structured peri-procedural nursing Intervention
All participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy.
|
The structured peri-procedural nursing Intervention includes standardized patient education, procedral preparation, comminication, emotional support, and nursing care provided before, during, and after transrectal prostate biopsy.
All participants receive the same Intervention according to the predefined study protocol.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)
大体时间：Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.
|
To assess in resilience in men undergoing transrectal prostate biopsy after structured peri-procedural nursing Intervention.
|
Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in anxiety measured by the Hamilton Anxiety Rating Scale (HAM-A)
大体时间：Baseline (7 days before biopsy), and 2-3 weeks after biopsy following disclosure of histopathological results.
|
To assess changes in anxiety levels in men undergoing transrectal prostate biopsy following structured peri-procedural nursing Intervention.
|
Baseline (7 days before biopsy), and 2-3 weeks after biopsy following disclosure of histopathological results.
|
|
Change in lower urinary tract symptoms associated with the biopsy procedure and recovery.
大体时间：Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.
|
To assess changes in lower urinary tract symptoms associated with the biopsy procedure and recovery.
|
Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.
|
|
Pain intensity measured by the Numeric Rating Scale (NRS)
大体时间：0-24 hours after biopsy.
|
To assess pain intensity experienced after transrectal prostate biopsy.
|
0-24 hours after biopsy.
|
|
Perception of nursing care measured by a structured patient questionnaire
大体时间：0-24 hours after biopsy and 2-3 weeks after biopsy.
|
To assess patients perception of peri-procedural nursing care, comminication, emotional support, and information provided.
|
0-24 hours after biopsy and 2-3 weeks after biopsy.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Histopathological disgnosis after prostate biopsy
大体时间：2-3 weeks after prostate biopsy, when histopathological results are disclosed.
|
Histopathological biopsy results will be recorded and participants will be stratified into benign and malignant disgnosis groups for pre-specified subgroup analyses.
|
2-3 weeks after prostate biopsy, when histopathological results are disclosed.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Maja Ardjelan, MSc、University of Mostar
- 学习椅：Katica Pavlović, MD, PhD、University of Mostar
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月4日
初级完成 (估计的)
2027年7月4日
研究完成 (估计的)
2027年8月4日
研究注册日期
首次提交
2026年8月7日
首先提交符合 QC 标准的
2026年8月7日
首次发布 (实际的)
2026年8月12日
研究记录更新
最后更新发布 (实际的)
2026年8月12日
上次提交的符合 QC 标准的更新
2026年8月7日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- No. 229/26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data collected during this study will not be made publicly available.
Only aggregated study results will be published.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.