This prospective, randomized, controlled clinical trial was designed to evaluate the impact of video-based educational interventions on reducing anxiety, depression, and stress levels in patients undergoing cystoscopy for the first time. Cystoscopy is a diagnostic and therapeutic procedure used to examine the bladder and lower urinary tract and may cause significant anxiety and emotional distress, particularly among patients undergoing the procedure for the first time due to its invasive nature and unfamiliarity. This study was conducted at the Urology Clinic of Izmir Katip Celebi University Ataturk Training and Research Hospital, and included 180 adult patients scheduled for their first cystoscopy between May 15 and June 14, 2025.
Participants were randomized using an odd-even allocation method into two groups: (1) the Video Education Group, which received the standard written informed consent document along with a Turkish-dubbed educational animation video explaining the cystoscopy procedure in a clear and patient-friendly manner, and (2) the Control Group, which received only the standard written informed consent document without the video intervention. The educational animation video used in the study was developed by the European Association of Urology (EAU) and adapted with Turkish narration to improve patient comprehension. The video, approximately three minutes in duration, covered the anatomy of the lower urinary tract, the steps of the cystoscopy procedure, the sensations patients may experience during the procedure, and post-procedure expectations such as transient hematuria and mild discomfort. Patients in the video group watched the animation via their personal mobile devices using a QR code approximately 15-20 minutes prior to the procedure while waiting for cystoscopy.
The primary aim of the study was to determine whether the video-based educational intervention could reduce the short-term psychological distress associated with cystoscopy, with a focus on anxiety reduction as the primary outcome. Secondary aims included evaluating the effects of the intervention on stress and depressive symptoms measured using validated psychological assessment tools. These included the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) and Depression Subscale (HADS-D), the State-Trait Anxiety Inventory - State Form (STAI TX-I), and the Beck Depression Inventory (BDI), all of which have validated Turkish versions used to ensure consistency and accuracy in the patient population. Pain perception following the procedure was assessed using the Visual Analog Scale (VAS) as an additional secondary outcome. All measurements were taken immediately before the cystoscopy and within 30 minutes after the procedure to capture the acute psychological response to the intervention and the procedure itself.
Patients were included if they were over 18 years of age, scheduled for their first cystoscopy, and provided written informed consent. Exclusion criteria included a history of previous cystoscopy, active urinary tract infections, cognitive impairment, and the use of psychotropic medications, which could confound the psychological assessments. The cystoscopy procedure was performed using a 22Fr rigid cystoscope with a 30-degree optic, following the administration of 10 mL of 2% lidocaine gel intraurethrally for local anesthesia, ensuring standardization across all procedures. All procedures were conducted by the same experienced urology team in a controlled outpatient clinic environment to maintain procedural consistency and reduce operator-related variability.
Statistical analyses were conducted using Jamovi (version 2.6) and R (version 4.4.0). The normality of continuous data was evaluated using the Shapiro-Wilk test. Depending on the distribution, independent samples t-tests or Mann-Whitney U tests were used to compare differences between groups. A 2x2 repeated measures ANOVA was performed to analyze the effects of time (pre- and post-procedure), group (video vs. control), and the interaction between time and group on psychological outcomes. Subgroup analyses based on patients' education and employment status were conducted using multivariate repeated measures ANOVA with Bonferroni-adjusted post-hoc tests to assess the potential moderating effects of these variables on the intervention's effectiveness. Effect sizes were reported using partial eta squared (η²p) to indicate the magnitude of the observed effects.
A priori power analysis was conducted using G\*Power version 3.1, with a medium effect size (Cohen's d = 0.50), an alpha level of 0.05, and a desired power of 0.90, indicating a minimum required sample size of 86 participants per group, which was met by the final enrollment of 180 patients, ensuring the study was sufficiently powered to detect statistically significant differences.
The study adhered to ethical principles in accordance with the Declaration of Helsinki and was approved by the Izmir Katip Celebi University Health Research Ethics Committee (IRB#0242, Date: May 15, 2025). Written informed consent was obtained from all participants prior to enrollment in the study. No external funding influenced the study design, data collection, analysis, or reporting, ensuring the objectivity and independence of the research findings.
