AnxietyNCT07760688
Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy
A study testing Structured peri-procedural nursing Intervention in people with Anxiety and Biopsy, run by University of Mostar at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- What is being tested?
- Structured peri-procedural nursing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 4 Aug 2026to 4 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
University Clinical Hospital Mostar
Mostar, Federation of Bosnia and Herzegovina, 88000
Maja Ardjelan, MSc, 00387 36 336 162, majaardjelan555@gmail.com
About this study
Official 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
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.
Read the 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.
- Being tested
- Structured peri-procedural nursing Intervention
- 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
- Medical subject headings
- Anxiety Disorders, Prostatic Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured peri-procedural nursing InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured peri-procedural nursing Intervention | Experimental | All participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy. Receives: Behavioral: Structured peri-procedural nursing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
To assess changes in anxiety levels in men undergoing transrectal prostate biopsy following structured peri-procedural nursing Intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-24 hours after biopsy and 2-3 weeks after biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start4 Aug 2026
- Primary completion4 Jul 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same structured peri-procedural nursing Intervention and will be followed longitudinally at predefined study time points.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Arđelan, University of Mostar
- Investigators
- Maja Ardjelan, MSc, Principal investigator, University of MostarKatica Pavlović, MD, PhD, Study chair, University of Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760688
- Sponsor's protocol ID
- No. 229/26
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available. Only aggregated study results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07760688
- Acronym / sponsor ID
- No. 229/26
- Keywords
- Prostate biopsy, Resilience, Nursing Intervention, Periprocedural nursing care, Prostate cancer, Patient education, Lower urinary tract symptoms, Hamilton Anxiety Rating Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 4 Jul 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same structured peri-procedural nursing Intervention and will be followed longitudinally at predefined study time points.
| Arm | Type | Receives |
|---|---|---|
| Structured peri-procedural nursing Intervention | Experimental | Behavioral: Structured peri-procedural nursing InterventionAll participants receive the same structured peri-procedural nursing Intervention before and after transrectal prostate biopsy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured peri-procedural nursing InterventionThe 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. | Behavioural | Structured peri-procedural nursing Intervention |
Primary outcome
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.
4 secondary outcomes
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.
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.
Pain intensity measured by the Numeric Rating Scale (NRS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available. Only aggregated study results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maja Ardjelan, MSc principal investigator
University of Mostar
Katica Pavlović, MD, PhD study chair
University of Mostar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured peri-procedural nursing Intervention in people with Anxiety and Biopsy, run by University of Mostar at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maja Ardjelan, MSc (00387 36 336 162, majaardjelan555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.