Video Education to Reduce Anxiety and Depression Before Cystoscopy: A Study in First-Time Patients

NCT ID: NCT07101211

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-06-14

Brief Summary

This study looks at whether watching a short educational video before a cystoscopy can help reduce feelings of anxiety, stress, and depression in patients having the procedure for the first time. Cystoscopy is a test that helps doctors see inside the bladder and urinary tract. It can cause worry or fear, especially for patients who have never had it before. In this study, 180 adult patients were divided into two groups. One group received standard written information about the procedure, and the other group received the same written information plus a short, easy-to-understand animation video that explains what will happen during cystoscopy. The video shows what patients might feel, what the procedure looks like, and what to expect afterward. The study measured how patients felt before and after the procedure to see if the video helped them feel calmer and more prepared. The goal is to find out if using videos before medical procedures can improve the patient experience and reduce stress and anxiety.

Detailed Description

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.

Conditions

Anxiety; Depression Anxiety Disorder; Stress, Psychological; Cystoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Video-Based Education + Standard Written Information

Participants in this arm received the standard written informed consent form for cystoscopy along with a Turkish-dubbed educational animation video explaining the cystoscopy procedure. The video was provided via a QR code to allow patients to watch it on their mobile devices while waiting for the procedure. The video covered the procedure steps, sensations to expect, and post-procedure care.

Group Type: EXPERIMENTAL

Video-Based Educational Animation

Intervention Type: BEHAVIORAL

A short, Turkish-dubbed educational animation video explaining the cystoscopy procedure, including steps of the procedure, expected sensations, and post-procedure care. The video is viewed by patients via QR code on their mobile devices before the cystoscopy to enhance patient understanding and reduce anxiety, stress, and depression.

Standard Written Informed Consent

Intervention Type: OTHER

A standard written informed consent form describing the cystoscopy procedure, including the purpose, steps, possible sensations, and post-procedure care, provided to all participants before the procedure.

Standard Written Information Only

Participants in this arm received only the standard written informed consent form describing the cystoscopy procedure. No video-based educational intervention was provided before the procedure.

Group Type: ACTIVE_COMPARATOR

Standard Written Informed Consent

Intervention Type: OTHER

A standard written informed consent form describing the cystoscopy procedure, including the purpose, steps, possible sensations, and post-procedure care, provided to all participants before the procedure.

Interventions

Video-Based Educational Animation

A short, Turkish-dubbed educational animation video explaining the cystoscopy procedure, including steps of the procedure, expected sensations, and post-procedure care. The video is viewed by patients via QR code on their mobile devices before the cystoscopy to enhance patient understanding and reduce anxiety, stress, and depression.

Intervention Type: BEHAVIORAL

Standard Written Informed Consent

A standard written informed consent form describing the cystoscopy procedure, including the purpose, steps, possible sensations, and post-procedure care, provided to all participants before the procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Undergoing first-time cystoscopy
• Provided written informed consent

Exclusion Criteria

• History of previous cystoscopy
• Active urinary tract infection
• Cognitive impairment
• Current use of psychotropic medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: collaborator

Enis Mert Yorulmaz

OTHER

Sponsor Role: lead

Responsible Party

Enis Mert Yorulmaz

Assistant Professor of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Enis M Yorulmaz, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Izmir Katip Celebi University

Locations

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

McClintock G, Wong E, Mancuso P, Lalak N, Gassner P, Haghighi K, Rathore P, McAulay L, Jeffery N. Music during flexible cystoscopy for pain and anxiety - a patient-blinded randomised control trial. BJU Int. 2021 Oct;128 Suppl 1:27-32. doi: 10.1111/bju.15527. Epub 2021 Jul 30.

Reference Type: RESULT

PMID: 34174137 (View on PubMed)

Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.

Reference Type: RESULT

PMID: 24548148 (View on PubMed)

Gauba A, Ramachandra MN, Saraogi M, Geraghty R, Hameed BMZ, Abumarzouk O, Somani BK. Music reduces patient-reported pain and anxiety and should be routinely offered during flexible cystoscopy: Outcomes of a systematic review. Arab J Urol. 2021 Mar 3;19(4):480-487. doi: 10.1080/2090598X.2021.1894814. eCollection 2021.

Reference Type: RESULT

PMID: 34881066 (View on PubMed)

Kwon OS, Kwon B, Kim J, Kim BH. Effects of Heating Therapy on Pain, Anxiety, Physiologic Measures, and Satisfaction in Patients Undergoing Cystoscopy. Asian Nurs Res (Korean Soc Nurs Sci). 2022 May;16(2):73-79. doi: 10.1016/j.anr.2022.02.002. Epub 2022 Feb 20.

Reference Type: RESULT

PMID: 35196580 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.youtube.com/watch?v=0faFfYsaOKs

Video animation of the cystoscopy procedure (prepared by EAU). This video was shown to the patients in the intervention group with Turkish dubbing.

Other Identifiers

IRB0242IKCU

Identifier Type: -

Identifier Source: org_study_id