Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07760688

Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anxiety Anxiety Disorders Biopsy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Hospital Mostar

Mostar, Federation of Bosnia and Herzegovina, 88000, Bosnia and Herzegovina

Location status: Recruiting

Location contact

Maja Ardjelan, MSc

CONTACT

[email protected]

00387 36 336 162

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured peri-procedural nursing Intervention

Behavioral

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.

Primary outcomes

  1. Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25)

    Time frame: 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.

Secondary outcomes

  1. Change in anxiety measured by the Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: 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.

  2. Change 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.

    To assess changes in lower urinary tract symptoms associated with the biopsy procedure and recovery.

  3. Pain intensity measured by the Numeric Rating Scale (NRS)

    Time frame: 0-24 hours after biopsy.

    To assess pain intensity experienced after transrectal prostate biopsy.

  4. Perception of nursing care measured by a structured patient questionnaire

    Time frame: 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.

Other outcomes

  1. Histopathological disgnosis after prostate biopsy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maja Ardjelan, MSc

CONTACT

[email protected]

00387 36 336 162

Sponsors and collaborators

Lead sponsor

University of Mostar

Other

Registry information

Official study title

Impact of Structured Periprocedural Nursing Interventions on Resilience and Anxiety in Men Undergoing Transrectal Prostate Biopsy: A Prospective Longitudinal Interventions Study With Histopathological Stratification

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.