An interventional study of Structured peri-procedural nursing Intervention in Anxiety and Biopsy, sponsored by University of Mostar. Recruiting at 1 site in Bosnia and Herzegovina. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Mostar · Not applicable, Interventional, and Supportive care
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.
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:
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Mostar is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy.
Behavioral: Structured peri-procedural nursing Intervention
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.
Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)
To assess in resilience in men undergoing transrectal prostate biopsy after structured peri-procedural nursing Intervention.
Time frame: Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.
Change in anxiety measured by the Hamilton Anxiety Rating Scale (HAM-A)
To assess changes in anxiety levels in men undergoing transrectal prostate biopsy following structured peri-procedural nursing Intervention.
Time frame: 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.
To assess changes in lower urinary tract symptoms associated with the biopsy procedure and recovery.
Time frame: 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)
To assess pain intensity experienced after transrectal prostate biopsy.
Time frame: 0-24 hours after biopsy.
Perception of nursing care measured by a structured patient questionnaire
To assess patients perception of peri-procedural nursing care, comminication, emotional support, and information provided.
Time frame: 0-24 hours after biopsy and 2-3 weeks after biopsy.
Histopathological disgnosis after prostate biopsy
Histopathological biopsy results will be recorded and participants will be stratified into benign and malignant disgnosis groups for pre-specified subgroup analyses.
Time frame: 2-3 weeks after prostate biopsy, when histopathological results are disclosed.
Plan to share: No — Individual participant data collected during this study will not be made publicly available. Only aggregated study results will be published.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2027, 11 months after the start.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 11 months is close to that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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