About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Structured peri-procedural nursing Intervention
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Pain intensity measured by the Numeric Rating Scale (NRS)
To assess pain intensity experienced after transrectal prostate 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.
Other outcomes
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.
Sponsors and contacts
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