Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy

August 7, 2026 updated by: Maja Arđelan, University of Mostar

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bosnia and Herzegovina
    • Federation of Bosnia and Herzegovina
      • Mostar, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina, 88000
        • Recruiting
        • University Clinical Hospital Mostar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Structured peri-procedural nursing Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (7 days before biopsy), 0-24 hours after biopsy, and 2-3 weeks after biopsy.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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)
Time Frame: 0-24 hours after biopsy.
To assess pain intensity experienced after transrectal prostate biopsy.
0-24 hours after biopsy.
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.
0-24 hours after biopsy and 2-3 weeks after biopsy.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2-3 weeks after prostate biopsy, when histopathological results are disclosed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Mostar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maja Ardjelan, MSc, University of Mostar
  • Study Chair: Katica Pavlović, MD, PhD, University of Mostar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • No. 229/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during this study will not be made publicly available. Only aggregated study results will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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