Anxiety, Biopsy
Conditions
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
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.
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.
Interventions
BEHAVIORALStructured 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.
Sponsors
University of Mostar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All participants will receive the same structured peri-procedural nursing Intervention and will be followed longitudinally at predefined study time points.
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in resilience measured by the Connor-Davidson Resilience Scale (CD-RISC-25) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. |
| Pain intensity measured by the Numeric Rating Scale (NRS) | 0-24 hours after biopsy. | To assess pain intensity experienced after transrectal prostate biopsy. |
| Perception of nursing care measured by a structured patient questionnaire | 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. |
Countries
Bosnia and Herzegovina
Contacts
CONTACTMaja Ardjelan, MSc
PRINCIPAL_INVESTIGATORMaja Ardjelan, MSc
University of Mostar
STUDY_CHAIRKatica Pavlović, MD, PhD
University of Mostar
Outcome results
None listed