Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy

NCT07760688 | Recruiting

• 1 other identifier: No. 229/26
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Biopsy

Keywords

Prostate biopsy; Resilience; Nursing Intervention; Periprocedural nursing care; Prostate cancer; Patient education; Lower urinary tract symptoms; Hamilton Anxiety Rating Scale; International Prostate Symptom Score

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.

Secondary Outcomes (4)

• 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.

Other Outcomes (1)

• Histopathological disgnosis after prostate biopsy

  2-3 weeks after prostate biopsy, when histopathological results are disclosed.

Study Arms (1)

Structured peri-procedural nursing Intervention

EXPERIMENTAL

All participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy.

Behavioral: Structured peri-procedural nursing Intervention

Interventions

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.

Structured peri-procedural nursing Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mostar: lead

Study Sites (1)

University Clinical Hospital Mostar

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

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Prostatic Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maja Ardjelan, MSc

  University of Mostar

  PRINCIPAL INVESTIGATOR

• Katica Pavlović, MD, PhD

  University of Mostar

  STUDY CHAIR

Central Study Contacts

Maja Ardjelan, MSc

CONTACT

00387 36 336 162; majaardjelan555@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive the same structured peri-procedural nursing Intervention and will be followed longitudinally at predefined study time points.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: August 4, 2026
• Primary Completion (Estimated): July 4, 2027
• Study Completion (Estimated): August 4, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)