Impact of Structured Periprocedural Nursing Interventions on Resilience and Anxiety in Men Undergoing Transrectal Prostate Biopsy: A Prospective Longitudinal Interventions Study With Histopathological Stratification
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Structured peri-procedural nursing Intervention
All participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy.
干预措施: Structured peri-procedural nursing Intervention (Behavioral)
结局指标
主要结局
Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)
时间窗: 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.
次要结局
- Change in anxiety measured by the Hamilton Anxiety Rating Scale (HAM-A)(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.(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)(0-24 hours after biopsy.)
- Perception of nursing care measured by a structured patient questionnaire(0-24 hours after biopsy and 2-3 weeks after biopsy.)
研究者
Maja Arđelan
Principal Investigator
University of Mostar