PainNCT06079814
Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy
A study testing virtual reality intervention in people with Pain and Anxiety, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- virtual reality intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being literate,
- Being conscious,
- Ability to understand and speak Turkish and not have hearing or visual impairment,
- Agreeing to participate in the research.
Who cannot join
- Having a diagnosed psychiatric and mental illness,
- Patients diagnosed with epilepsy (due to the risk of virtual reality glasses triggering epileptic seizures),
- Patients who do not want to continue the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy: A Randomized Controlled Study
The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.
- Being tested
- virtual reality intervention
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality interventionOther
Patients will be shown content through the patient's virtual reality glasses throughout the cystoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | Patients will wear virtual reality glasses 10 minutes before cystoscopy. The content chosen by the patient (there will be three options) will be watched throughout the procedure. Receives: Other: virtual reality intervention |
| control group | No intervention | Standard procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of virtual reality applications on pain during cystoscopy
The patient's pain will be assessed using the 'Visual Analog Scale (VAS).' This scale involves marking on a 10 cm vertical or horizontal line, with one end indicating no pain at all and the other end indicating the most severe pain, to assess and measure the level of pain.
Measured: 30 minutes after the procedure
The effect of virtual reality applications on anxiety during cystoscopy
Procedure related anxiety will be assessed using the 'State Anxiety Inventory.' This inventory consists of a total of 20 items and the scoring ranges from 20 to 80 points. The higher the total score obtained from the scale, the higher the level of anxiety experienced by the individual is interpreted.
Measured: 30 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 Oct 2023
- Primary completion10 Sep 2024
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Yurtseven, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079814
- Sponsor's protocol ID
- 5312256929
- Status last verified
- Feb 2024
- First submitted
- 2 Oct 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06079814
- Acronym / sponsor ID
- 5312256929
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 12 Oct 2023 (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.
The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Other: virtual reality interventionPatients will wear virtual reality glasses 10 minutes before cystoscopy. The content chosen by the patient (there will be three options) will be watched throughout the procedure. |
| control group | No intervention | –Standard procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being literate,
- Being conscious,
- Ability to understand and speak Turkish and not have hearing or visual impairment,
- Agreeing to participate in the research.
Key exclusion criteria (3 listed)
- Having a diagnosed psychiatric and mental illness,
- Patients diagnosed with epilepsy (due to the risk of virtual reality glasses triggering epileptic seizures),
- Patients who do not want to continue the study
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 interventionPatients will be shown content through the patient's virtual reality glasses throughout the cystoscopy procedure. | Other | experiment group |
Primary outcome
The effect of virtual reality applications on pain during cystoscopy
Time frame: 30 minutes after the procedure
The patient's pain will be assessed using the 'Visual Analog Scale (VAS).' This scale involves marking on a 10 cm vertical or horizontal line, with one end indicating no pain at all and the other end indicating the most severe pain, to assess and measure the level of pain.
The effect of virtual reality applications on anxiety during cystoscopy
Time frame: 30 minutes after the procedure
Procedure related anxiety will be assessed using the 'State Anxiety Inventory.' This inventory consists of a total of 20 items and the scoring ranges from 20 to 80 points. The higher the total score obtained from the scale, the higher the level of anxiety experienced by the individual is interpreted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 intervention in people with Pain and Anxiety, run by Cukurova University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of virtual reality applications on pain during cystoscopy (time frame: 30 minutes after the procedure). The study lists 2 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 4 Aug 2026.