PainNCT07872137
The Effect of Virtual Reality Use in Cystoscopy on Pain, Anxiety, and Comfort: A Randomized Controlled Trial
A study testing Virtual Reality Distraction in people with Pain and Anxiety, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of virtual reality (VR) distraction on pain, anxiety, and comfort levels patients undergoing cystoscopy. Cystoscopy is a common diagnostic procedure in urology that can cause physical discomfort and anxiety in patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Anxiety, Patient Comfort
- What is being tested?
- Virtual Reality Distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 15 Jun 2026
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were 18 years of age or older, able to speak, understand, read, and write in Turkish, capable of communication, undergoing diagnostic flexible cystoscopy for the first time, male, and willing to participate in the study were included.
Who cannot join
- Patients with a history of previous cystoscopy, a diagnosis or history of epilepsy, claustrophobia, or cognitive impairment, and those with visual, hearing, or perceptual impairments that would prevent the use of VR goggles were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70100
About this study
This study aims to evaluate the effects of virtual reality (VR) distraction on pain, anxiety, and comfort levels patients undergoing cystoscopy. Cystoscopy is a common diagnostic procedure in urology that can cause physical discomfort and anxiety in patients. This randomized controlled trial assigns eligible participants to either an experimental group receiving VR video distraction during the procedure or a control group receiving standard care without VR intervention. Pain, anxiety, and comfort levels are assessed and compared between the two groups using standardized measurement tools.
- Conditions
- Pain, Anxiety, Patient Comfort, Cystoscopy
- Being tested
- Virtual Reality Distraction, Standard Care
- Keywords
- Virtual Reality, Cystoscopy, Nursing Care, pain, anxiety, comfort
- 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 DistractionDevice
Participants wore VR goggles displaying relaxing videos (nature, sea views) with soothing background music during the entire cystoscopy procedure.
Standard CareOther
Routine clinical management and standard nursing care provided during cystoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Group | Experimental | Not described Receives: Device: Virtual Reality Distraction |
| Control Group | Active comparator | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain level measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "unbearable/very severe".
Measured: Baseline (before the procedure) and immediately after the procedure
Comfort Score
Patient comfort level evaluated using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no comfort at all" and 10 indicates "excellent" comfort.
Measured: Baseline (before the procedure) and immediately after the procedure
State Anxiety Score
State anxiety level measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). Scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: Baseline (before the procedure) and immediately 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 posted13 Oct 2026
- Study start2 Mar 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
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.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAMZE GOKE ARSLAN, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872137
- Sponsor's protocol ID
- 09-2025/133
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Use in Cystoscopy on Pain, Anxiety, and Comfort: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07872137
- Acronym / sponsor ID
- 09-2025/133
- Conditions
- Pain, Anxiety, Patient Comfort, Cystoscopy
- Keywords
- Virtual Reality, Cystoscopy, Nursing Care, pain, anxiety, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 13 Oct 2026 (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 study aims to evaluate the effects of virtual reality (VR) distraction on pain, anxiety, and comfort levels patients undergoing cystoscopy. Cystoscopy is a common diagnostic procedure in urology that can cause physical discomfort and anxiety in patients. This randomized controlled trial assigns eligible participants to either an experimental group receiving VR video distraction during the procedure or a control group receiving standard care without VR intervention. Pain, anxiety, and comfort levels are assessed and compared between the two groups using standardized measurement tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Group | Experimental | Device: Virtual Reality Distraction |
| Control Group | Active comparator | Other: Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were 18 years of age or older, able to speak, understand, read, and write in Turkish, capable of communication, undergoing diagnostic flexible cystoscopy for the first time, male, and willing to participate in the study were included.
Key exclusion criteria (1 listed)
- Patients with a history of previous cystoscopy, a diagnosis or history of epilepsy, claustrophobia, or cognitive impairment, and those with visual, hearing, or perceptual impairments that would prevent the use of VR goggles were excluded from 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 DistractionParticipants wore VR goggles displaying relaxing videos (nature, sea views) with soothing background music during the entire cystoscopy procedure. | Device | Virtual Reality (VR) Group |
| Standard CareRoutine clinical management and standard nursing care provided during cystoscopy procedure. | Other | Control Group |
Primary outcome
Pain Score
Time frame: Baseline (before the procedure) and immediately after the procedure
Pain level measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "unbearable/very severe".
Comfort Score
Time frame: Baseline (before the procedure) and immediately after the procedure
Patient comfort level evaluated using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no comfort at all" and 10 indicates "excellent" comfort.
State Anxiety Score
Time frame: Baseline (before the procedure) and immediately after the procedure
State anxiety level measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). Scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
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 16 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect participant privacy.
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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 Distraction in people with Pain and Anxiety, run by Karamanoğlu Mehmetbey 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 1 inclusion and 1 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 16 Oct 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?
Pain Score (time frame: Baseline (before the procedure) and immediately after the procedure). 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 16 Oct 2026.