NCT07101211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

June 29, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Video-based educationCystoscopyAnxietyPsychological stressDepression

Outcome Measures

Primary Outcomes (2)

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

    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.

    Immediately before cystoscopy and within 30 minutes post-procedure

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

    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.

    Immediately before cystoscopy and within 30 minutes post-procedure

Secondary Outcomes (2)

  • Change in Depression Levels Assessed by HADS-D Before and After Cystoscopy

    Immediately before cystoscopy and within 30 minutes post-procedure

  • Change in Depression Levels Assessed by Beck Depression Inventory (BDI) Before and After Cystoscopy

    Immediately before cystoscopy and within 30 minutes post-procedure

Other Outcomes (2)

  • Effect of Patient Education Level on Change in Anxiety Levels Measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Before and After Cystoscopy

    Immediately before cystoscopy and within 30 minutes post-procedure

  • Effect of Patient Education Level on Change in State Anxiety Levels Measured by the State-Trait Anxiety Inventory - State Form (STAI TX-I) Before and After Cystoscopy

    Immediately before cystoscopy and within 30 minutes post-procedure

Study Arms (2)

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.

Behavioral: Video-Based Educational AnimationOther: Standard Written Informed Consent

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.

Other: Standard Written Informed Consent

Interventions

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.

Video-Based Education + Standard Written Information

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 OnlyVideo-Based Education + Standard Written Information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Anxiety DisordersStress, PsychologicalDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Enis M Yorulmaz, Assist Prof

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a parallel design to one of two groups: a control group receiving standard written information about cystoscopy, and an intervention group receiving the same written information plus an educational animation video prior to the procedure. Outcomes were assessed pre- and post-procedure in both groups to compare the effects of video-based education on anxiety, stress, and depression levels.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

June 29, 2025

First Posted

August 3, 2025

Study Start

May 15, 2025

Primary Completion

June 14, 2025

Study Completion

June 14, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data (IPD) from this study. However, IPD may be considered for sharing upon reasonable request from journal editors or qualified researchers, in compliance with institutional policies and data protection regulations.

Locations