Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy (NCT07760688) | Clinical Trial Compass
RecruitingNot Applicable
Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy
Bosnia and Herzegovina120 participantsStarted 2026-08-04
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)
Timeframe: Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.