CystoscopyNCT06342193
Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial
A study testing virtual reality group in people with Cystoscopy and Virtual Reality, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cystoscopy, Virtual Reality, Anxiety
- What is being tested?
- virtual reality group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2024to 15 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- 18 years of age or older
- Male gender
- undergoing a rigid cystoscopy procedure for the first time
- Application of local anaesthesia
Who cannot join
- Cognitive or physical disabilities that may prevent the use of virtual reality glasses.
- Premedication before the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Usak Training and Research Hospital
Uşak, Center, 64100
Yucel Can Danisman, +905532864569, 202201023@ogr.usak.edu.tr
Fatma Susam, PhD
About this study
The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.
- Conditions
- Cystoscopy, Virtual Reality, Anxiety
- Being tested
- virtual reality group
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality groupDevice
This group will use virtual reality glasses as distraction during cystoscopy.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | This group will use virtual reality glasses during cystoscopy. Receives: Device: virtual reality group |
| controlled group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety
State Trait Anxiety Scale-Situational Anxiety Scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start14 Mar 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yucel Can Danisman, Principal investigator, Usak University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342193
- Sponsor's protocol ID
- virtual reality
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06342193
- Acronym / sponsor ID
- virtual reality
- Conditions
- Cystoscopy, Virtual Reality, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 2 Apr 2024 (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 study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: virtual reality groupThis group will use virtual reality glasses during cystoscopy. |
| controlled group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the research
- 18 years of age or older
- Male gender
- undergoing a rigid cystoscopy procedure for the first time
- Application of local anaesthesia
Key exclusion criteria (2 listed)
- Cognitive or physical disabilities that may prevent the use of virtual reality glasses.
- Premedication before the procedure
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 groupThis group will use virtual reality glasses as distraction during cystoscopy. | Device | intervention group |
Primary outcome
anxiety
Time frame: 30 minutes
State Trait Anxiety Scale-Situational Anxiety Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
Yucel Can Danisman principal investigator
Usak University Training and Research Hospital
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 group in people with Cystoscopy and Virtual Reality, run by Uşak 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 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilgen Arikan, PhD (+902762212121 ext. 3081, blgnkhy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: 30 minutes). 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 2 Apr 2024.