Can pain and anxiety be reduced in cystoscopy?
| ISRCTN | ISRCTN22513446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22513446 |
- Submission date
- 04/09/2025
- Registration date
- 05/09/2025
- Last edited
- 05/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Flexible cystoscopy is a routine outpatient procedure used to examine the bladder. Although it is generally safe, many patients feel anxious and experience discomfort during the procedure. This study is testing whether two simple, non-invasive methods, showing patients a short educational video before the procedure and using virtual reality (VR) distraction during the procedure, can make the experience less stressful and less painful.
Who can participate?
Adult patients who need flexible cystoscopy at Ümraniye Training and Research Hospital
What does the study involve?
Patients will be randomly assigned to one of four groups: (1) video only, (2) video + VR, (3) VR only, and (4) routine care without video or VR. The video explains the procedure in simple terms, while the VR headset shows calming 360° nature scenes.
The study will measure patients' long-term tendency to experience anxiety and their current state of anxiety using questionnaires before and immediately after the procedure. Pain intensity will be assessed during cystoscopy using a scale. All procedures will be performed by experienced urologists under local anaesthesia, and data will be collected by a second physician.
What are the possible benefits and risks of participating?
The results of this study will help determine whether video education and VR distraction are effective in reducing anxiety and pain during flexible cystoscopy, and may guide improvements in patient care.
No risks given at registration.
Where is the study run from?
Ümraniye Training and Research Hospital, Department of Urology.
When is the study starting and how long is it expected to run for?
October 2024 to January 2025
Who is funding the study?
Ümraniye Training and Research Hospital, Department of Urology. (no external funding)
Who is the main contact?
Dr Murat Beyatlı, muratbeyatli_90@hotmail.com
Contact information
Public, Scientific, Principal Investigator
Elmalıkent Mahallesi Adem Yavuz Cad. No:1 Ümraniye / İstanbul
İstanbul
34764
Türkiye
 ORCID ID |
0000-0003-0945-0051 |
|---|---|
| Phone | +905556405515 |
| muratbeyatli_90@hotmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of pre-procedural video education and intra-procedural virtual reality on anxiety and pain during flexible cystoscopy: a randomized controlled trial |
| Study acronym | VR-CYSTO |
| Study objectives | To evaluate whether pre-procedural video education and intra-procedural virtual reality distraction reduce anxiety and pain compared to standard care in patients undergoing flexible cystoscopy. |
| Ethics approval(s) |
Approved 07/11/2024, Ümraniye Training and Research Hospital Ethics Committee (Elmalıkent Neighborhood Adem Yavuz Street No:1, Ümraniye/Istanbul, 34760, Türkiye; +90 (0216) 632 18 18/11 64; not@available.com), ref: 370 |
| Health condition(s) or problem(s) studied | Procedural anxiety and pain in patients undergoing flexible cystoscopy |
| Intervention | Randomisation is 1:1:1:1 using computer-generated allocation. Participants are randomised into four parallel arms: 1. Pre-procedural educational video + VR headset during cystoscopy; 2. Educational video only; 3. VR headset only; 4. Control group receiving standard care (no video, no VR). The video lasts ~3 minutes and explains the cystoscopy procedure. The VR headset shows neutral, relaxing content during the procedure until completion (average 5–10 minutes). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Pain intensity measured using the Visual Analogue Scale (VAS, 0–10) during the cystoscopy procedure 2. State anxiety measured using the State-Trait Anxiety Inventory – State (STAI-S) at baseline (before cystoscopy) and immediately after the procedure |
| Secondary outcome measures | 1. Trait anxiety measured using the State-Trait Anxiety Inventory – Trait (STAI-T) at baseline only, before the procedure. 2. Adverse events, defined as any complications or side effects observed during or after cystoscopy (e.g., dizziness, nausea, vasovagal symptoms), measured using medical records at one timepoint |
| Overall study start date | 07/10/2024 |
| Completion date | 30/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 240 |
| Key inclusion criteria | 1. Age ≥18 years 2. Indication for flexible cystoscopy 3. Adequate cognitive function |
| Key exclusion criteria | 1. Current use of anxiolytics, antidepressants, or opioids 2. Prior history of cystoscopy 3. Significant cognitive or psychiatric disorders 4. Severe hearing/visual impairment preventing video or VR use 5. Active urinary tract infection or chronic bladder pain 6. History of severe allergic reaction to local anesthetics 7. Pregnancy |
| Date of first enrolment | 08/11/2024 |
| Date of final enrolment | 30/01/2025 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Istanbul
34764
Türkiye
Sponsor information
Hospital/treatment centre
Elmalıkent Mahallesi Adem Yavuz Cad. No:1 Ümraniye
Istanbul
34764
Türkiye
| Phone | +90(216) 632 18 18 |
|---|---|
| ueahrg@gmail.com | |
| Website | https://umraniyeah.saglik.gov.tr/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 20/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings of this trial will be submitted for publication in a peer-reviewed scientific journal within one year of study completion and may also be presented at national and international urology conferences |
| IPD sharing plan | De-identified or anonymised datasets of individual participant data (IPD) will be made available from the corresponding author (Murat Beyatlı, muratbeyatli_90@hotmail.com) on reasonable request after publication of the study results. Data will be shared for academic purposes only, in anonymised form, without any information that could identify individual participants. |
Editorial Notes
05/09/2025: Study's existence confirmed by the Ümraniye Training and Research Hospital Ethics Committee.
