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临床试验/NCT07101211
NCT07101211已完成不适用

Effect of Video-Based Information on Anxiety, Depression, and Stress Before Cystoscopy: A Prospective Randomized Controlled Tria

Enis Mert Yorulmaz1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Change in Anxiety Levels Assessed by STAI Form TX-I Before and After Cystoscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors who evaluated anxiety, stress, and depression scores using the HADS-A, HADS-D, STAI-TX-I, and BDI were blinded to group allocation to reduce assessment bias. This blinding ensured that the assessors were unaware of whether participants had received video-based education or only written information before cystoscopy. The blinding was implemented according to SPIRIT guidelines for clinical trial design to maintain the integrity of outcome evaluations and reduce potential bias in analyzing the psychological effects of the intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Video-Based Education + Standard Written Information

Experimental

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.

干预措施: Video-Based Educational Animation (Behavioral)

Video-Based Education + Standard Written Information

Experimental

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.

干预措施: Standard Written Informed Consent (Other)

Standard Written Information Only

Active Comparator

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.

干预措施: Standard Written Informed Consent (Other)

结局指标

主要结局

Change in Anxiety Levels Assessed by STAI Form TX-I Before and After Cystoscopy

时间窗: Immediately before cystoscopy and within 30 minutes post-procedure

The State-Trait Anxiety Inventory - State Form (STAI Form TX-I) is a 20-item self-report scale measuring temporary, situation-specific anxiety. Each item is rated on a 4-point Likert scale, with scores ranging from 20 to 80. Higher scores indicate more severe state anxiety. Some items are reverse scored. Typical interpretations: 20-37 (low), 38-44 (moderate), ≥45 (high anxiety). The Turkish version was validated by Öner \& LeCompte (1983). It is widely used in procedural settings to assess acute stress responses and emotional tension before and after interventions such as cystoscopy. Turkish Validation: Öner, Necla, William Ayhan LeCompte. Durumluk Surekli Kaygi Envanteri El Kitabi, Bogazici Universitesi Yayinlari, Istanbul, 1-26. (In Turkish). 1983.

Change in Anxiety Levels Assessed by HADS-A Before and After Cystoscopy

时间窗: Immediately before cystoscopy and within 30 minutes post-procedure

The Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) assesses anxiety symptoms in patients while minimizing the influence of physical illness. It includes 7 items scored from 0 to 3, with a total score range of 0-21. Scores are interpreted as: 0-7 normal, 8-10 borderline, 11-21 abnormal. It avoids somatic symptoms and is widely validated across medical settings. The Turkish version used in this study was validated by Aydemir (1997). Due to its brevity and focus on emotional symptoms, HADS-A is suitable for measuring procedural anxiety before and after interventions such as cystoscopy. Turkish Validation: Aydemir O. Validity and Reliability of Turkish Version of Hospital Anxiety and Depression Scale. Turkish Journal of Psychiatry. 1997 Apr;8:280-7.

次要结局

  • Change in Depression Levels Assessed by Beck Depression Inventory (BDI) Before and After Cystoscopy(Immediately before cystoscopy and within 30 minutes post-procedure)
  • Change in Depression Levels Assessed by HADS-D Before and After Cystoscopy(Immediately before cystoscopy and within 30 minutes post-procedure)

研究者

发起方
Enis Mert Yorulmaz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Enis Mert Yorulmaz

Assistant Professor of Urology

Izmir Katip Celebi University

研究点 (1)

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