Virtual RealityNCT07017660
Virtual Reality Application During Cystoscopy
A study testing virtual reality glasses in people with Virtual Reality and Rigid Cystoscopy, run by Ayten Akkaya at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study aimed to determine the effect of virtual reality glasses during cystoscopy on pain, anxiety and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Virtual Reality, Rigid Cystoscopy
- What is being tested?
- virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older,
- First elective and rigid cystoscopy performed under local anesthesia,
- No vision, hearing and perception problems,
- Open to communication and able to speak Turkish,
- Patients who agree to participate in the study
Who cannot join
- Contraindications for the procedure (lidocaine allergy, urinary tract infection, anatomical problems related to the urethra, etc.)
- Use of any analgesic or sedative medication at least 4 hours before cystoscopy Patients who undergo manipulation such as J stent placement or removal and/or bladder biopsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara
Ankara Etlik City Hospital, +90 0 312 797 00 00, etliksh.iletisim@saglik.gov.tr
Hasan N. G. Göktuğ, PhD
About this study
Official title: Effect of Virtual Reality Application on Pain, Anxiety and Patient Satisfaction During Cystoscopy: A Randomized Controlled Trial
This randomized controlled experimental study aimed to determine the effect of virtual reality glasses during cystoscopy on pain, anxiety and patient satisfaction.
Read the detailed description
Patients in the intervention arm; In order to evaluate pain, anxiety and patient satisfaction regarding the cystoscopy procedure, the patient's pain level will be assessed with the Visual Analog Scale 10 minutes before the procedure and the patient's anxiety level will be assessed with the State Anxiety Scale. Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction level will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale.
Patients in the control arm; To assess pain, anxiety, and patient satisfaction with the cystoscopy procedure, the patient's pain level will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale 10 minutes before the procedure. Routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction levels will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale.
- Conditions
- Virtual Reality, Rigid Cystoscopy
- Being tested
- virtual reality glasses, No intervention
- Keywords
- Cystoscopy, Pain, anxiety, satisfaction, virtual reality
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesOther
Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until it is completed. With the virtual reality glasses, the patient will be shown a video of nature scenes and made to listen to the sounds of water and birds. Routine institutional procedures will be applied during the cystoscopy procedure.
No interventionOther
Routine institution procedures will be applied during the cystoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Routine institution procedures will be applied during the cystoscopy procedure. Receives: Other: No intervention |
| virtual reality glasses | Experimental | Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure. Receives: Other: virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale
Rating is done on a scale with a 10 cm horizontal or vertical ruler and "0" means dissatisfaction and "10" means the highest level of satisfaction.
Measured: 1 day
Visual Analog Scale
Grading is made with a 10 cm long horizantal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
Measured: 1 day
Spielberg State Anxiety Scale
The scale has a four-point Likert structure consisting of 20 items, and a total score of 20-80 is obtained.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start11 Jun 2025
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayten Akkaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayten Akkaya, Ankara Medipol University
- Investigators
- Ayten Akkaya, PhD, Principal investigator, Ankara Medipol University Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017660
- Sponsor's protocol ID
- 2025-022
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Application on Pain, Anxiety and Patient Satisfaction During Cystoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07017660
- Acronym / sponsor ID
- 2025-022
- Conditions
- Virtual Reality, Rigid Cystoscopy
- Keywords
- Cystoscopy, Pain, anxiety, satisfaction, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ayten AkkayaUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled experimental study aimed to determine the effect of virtual reality glasses during cystoscopy on pain, anxiety and patient satisfaction.
Detailed description
Patients in the intervention arm; In order to evaluate pain, anxiety and patient satisfaction regarding the cystoscopy procedure, the patient's pain level will be assessed with the Visual Analog Scale 10 minutes before the procedure and the patient's anxiety level will be assessed with the State Anxiety Scale. Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction level will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale.
Patients in the control arm; To assess pain, anxiety, and patient satisfaction with the cystoscopy procedure, the patient's pain level will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale 10 minutes before the procedure. Routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction levels will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: No interventionRoutine institution procedures will be applied during the cystoscopy procedure. |
| virtual reality glasses | Experimental | Other: virtual reality glassesPatients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older,
- First elective and rigid cystoscopy performed under local anesthesia,
- No vision, hearing and perception problems,
- Open to communication and able to speak Turkish,
- Patients who agree to participate in the study
Key exclusion criteria (2 listed)
- Contraindications for the procedure (lidocaine allergy, urinary tract infection, anatomical problems related to the urethra, etc.)
- Use of any analgesic or sedative medication at least 4 hours before cystoscopy Patients who undergo manipulation such as J stent placement or removal and/or bladder biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality glassesPatients will be asked to wear virtual reality glasses starting three minutes before the procedure and until it is completed. With the virtual reality glasses, the patient will be shown a video of nature scenes and made to listen to the sounds of water and birds. Routine institutional procedures will be applied during the cystoscopy procedure. | Other | virtual reality glasses |
| No interventionRoutine institution procedures will be applied during the cystoscopy procedure. | Other | control group |
Primary outcome
Visual Analog scale
Time frame: 1 day
Rating is done on a scale with a 10 cm horizontal or vertical ruler and "0" means dissatisfaction and "10" means the highest level of satisfaction.
Visual Analog Scale
Time frame: 1 day
Grading is made with a 10 cm long horizantal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
Spielberg State Anxiety Scale
Time frame: 1 day
The scale has a four-point Likert structure consisting of 20 items, and a total score of 20-80 is obtained.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayten Akkaya, PhD principal investigator
Ankara Medipol University Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses in people with Virtual Reality and Rigid Cystoscopy, run by Ayten Akkaya at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayten Akkaya, PhD (+905052931663, aytenkoc81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog scale (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.