Evaluate the Impact of Dynamic Video Education Versus Static Images and Verbal Instruction on Pain Perception and Anxiety in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy (TRUS-Bx).
Phase: NA
Conditions: Prostate Cancer, Prostate Biopsy, Anxiety
Sponsor: Ankara Etlik City Hospital

Official Title: 
Evaluation the Effects of Dynamic Video Education Compared to Static Images and Verbal 
Information on Pain Perception and Anxiety in Patients Undergoing Transrectal Ultrasound-
guided Prostate Biopsy (TRUS-Bx) 
National Ethics Committee Number: AEŞH-EK1-2023-100 
Date: 10/12/2023 
RESEARCH PROTOCOL 
CLINICAL RESEARCH (Studies excluding medications, test kits, or medical devices) 
1. Full Title of the Study:
"A Prospective Comparative Study of the Effect of Video Education on Pain and Anxiety 
in Patients Undergoing TRUS-Guided Prostate Biopsy" 
2. Purpose and Significance of the Study:
The widespread use of PSA (Prostate-Specific Antigen) has facilitated the early detection of 
prostate cancer. Biopsies are performed on patients who are suspected to have prostate cancer 
based on elevated PSA and digital rectal examination. Transrectal ultrasound-guided prostate 
biopsy is the standard diagnostic procedure. The increasing use of PSA has led to a rise in the 
number of biopsies. 
It has been reported that prostate biopsies and the diagnosis of prostate cancer cause anxiety 
in men. These procedures may lead to pain, anxiety, and stress. 
Today, patients frequently use the internet to gather information. Watching videos of 
procedures before surgery via digital platforms is common. This study aims to measure the 
effect of watching TRUS-BX videos before and after the procedure on patients' anxiety and 
stress levels. 
3. Expected Benefits and Risks:

If an increase in patients' anxiety and stress scores is observed, it may highlight the need for 
additional measures to inform patients prior to procedures. Videos could be adjusted to 
reduce stress, potentially making the biopsy experience more comfortable. However, patients 
who become overly anxious after watching such videos might delay or avoid diagnosis and 
treatment, as seen in psychiatric consultations. This study may also guide how digital content 
should be curated. 
 
4. Study Design: 
This is a comparative study of anxiety scores and visual analog scale (VAS) pain scores 
before and after the procedure. All patients are informed in the outpatient clinic about the 
TRUS-BX procedure after elevated PSA is detected. 
The study was reviewed and finalized with the contributions of Dr. Ayşe Gökçen Gündoğmuş 
from the Psychiatry Department of Ankara Etlik City Hospital. 
Control Group: 
Patients are given verbal information about the procedure. Then: 
• 
VAS test is applied. 
• 
STAI-II (Trait Anxiety) and STAI-I (State Anxiety) scales are administered pre-
procedure. 
• 
After biopsy: VAS and STAI-I are re-administered. 
• 
No visual material is shown. 
Video Group: 
Patients are given verbal information. Then: 
• 
VAS test is applied. 
• 
Videos about the procedure are found and watched with the patients via digital video 
platforms. 
• 
STAI-II and STAI-I are administered pre-procedure. 
• 
After biopsy: VAS and STAI-I are re-administered. 
Image Group: 
Patients are given verbal information. Then: 
• 
VAS test is applied. 
• 
Illustrated drawings (from books) about the procedure are shown to the patients. 
• 
STAI-II and STAI-I are administered pre-procedure. 
• 
After biopsy: VAS and STAI-I are re-administered. 
 
5. Target Volunteer Group: 

Adult males with elevated PSA levels and planned biopsy. 
 
6. Age Range: 
Men aged 50–80 (PSA screening typically begins at age 50 and is not routinely done after 75 
unless clinically indicated). 
 
 
7. Sample Size: 
No similar study was found in the literature. There are three independent groups: 
• 
Video group, 
• 
No visual group, 
• 
Image group. 
• 
Assuming an alpha (α) level of 0.05 and a beta (β) level of 0.20 (power of 80%), and 
an effect size (Cohen’s f) of 0.40, it was calculated that approximately 26 participants 
per group (78 in total) would be required to detect meaningful differences between the 
three groups. 
 
 
8. Inclusion Criteria: 
• 
Male patients aged 50–80 
• 
Biopsy planned due to elevated PSA 
• 
Voluntary participation 
 
9. Exclusion Criteria: 
• 
Organic mental disorders, dementia, depressive and anxiety disorders, PTSD, acute 
psychotic or bipolar disorders 
• 
Patients with cognitive or physical impairments that prevent informed consent (e.g., 
blindness, moderate to severe mental retardation) 
• 
Panic disorder diagnosis 
• 
Patients with pre-procedure VAS ≥ 5, suggestive of significant anxiety-stress 
disorders 
 
10. Withdrawal Criteria: 

• 
Participants may withdraw at any time. 
• 
Patients who become excessively anxious or restless during biopsy will have the 
procedure rescheduled under general anesthesia and be excluded from the study. 
 
11. Parameters to be Measured: 
• 
Age 
• 
PSA levels 
• 
Subjective findings of rectal examination 
• 
Post-procedure complications 
• 
Anxiety and stress scores (STAI-I and II, pre-op and post-op) 
• 
Pain scores (VAS) 
 
12. Where and by Whom Parameters Will Be Collected: 
All patients will be recruited from the Urology outpatient clinics of Etlik City Hospital. 
Assessments will be carried out by Clinical Urology Physicians. 
 
13. Routine vs. Study-Specific Parameters: 
All parameters are part of routine clinical evaluations for patients with high PSA. No study-
specific laboratory or additional tests will be requested. 
 
14. Estimated Study Duration: 
• 
Start: 10.12.2023 
• 
End of patient recruitment: 30.12.2024 
• 
12 months of data collection, 5 months for manuscript preparation and submission 
• 
Total: 17 months 
 
15. Study Endpoint: 
• 
The study will conclude on 20.05.2025 
 
16. Criteria for Termination: 
• 
Data collection will end once sufficient data is collected. 

 
17. Outcome Evaluation: 
The primary endpoint is the tabulation and statistical analysis of STAI responses before and 
after the procedure among different groups. The secondary endpoint is the writing and 
publication of the study results. 
 
Previous literature has shown that prostate biopsy induces anxiety and depression. Zisman et 
al., in a prospective study of 211 men, found that 64% experienced decreased well-being and 
anxiety from the pre-biopsy period up to 30 days after. Fowler et al. showed that anxiety may 
persist for up to 12 months, even in patients with negative biopsy results. Our study seeks to 
answer whether pre-procedural videos intensify the anxiety already known to be associated 
with the biopsy. 
 
18. Statistical Analysis: 
Both parametric tests (t-test, ANOVA, Pearson correlation, linear regression) and non-
parametric tests (Wilcoxon, Mann-Whitney U, Kruskal-Wallis, Friedman, Spearman 
correlation) will be used. 
Descriptive statistical analyses will be performed using SPSS software (version 20, SPSS 
Inc., Chicago, USA). 
 
Name / Signature 
Principal Investigator: 
Fatih SANDIKÇI 
 
 
Statistical Analysis 
All statistical analyses were performed using SPSS software [insert version]. Continuous 
variables were expressed as mean ± standard deviation, and categorical data as frequencies and 
percentages. Group comparisons were made using the Kruskal-Wallis test for non-parametric 
data and ANOVA for normally distributed data. Post-hoc pairwise comparisons were 
conducted using the Mann-Whitney U test with Bonferroni correction. A p-value <0.05 was 
considered statistically significant. A priori power analysis was conducted using G*Power 

software version 3.1.9.7 to determine the adequate sample size. Assuming an alpha (α) level of 
0.05 and a beta (β) level of 0.20 (power of 80%), and an effect size (Cohen’s f) of 0.40, it was 
calculated that approximately 26 participants per group (78 in total) would be required to detect 
meaningful differences between the three groups.