Urinary IncontinenceNCT07277894
The Effect of Virtual Reality During Urodynamics on Vital Signs, Anxiety, and Satisfaction
A study testing Virtual reality group in people with Urinary Incontinence and Urodynamic Studies, run by Saglik Bilimleri Universitesi.
Trial summary
Study Topic This research aims to evaluate the effects of virtual reality (VR) application during noninvasive urodynamics on patients' vital signs, anxiety, and satisfaction levels. Significance of the Problem Urodynamic studies are essential diagnostic methods for assessing lower urinary tract functions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urodynamic Studies, Urodynamics
- What is being tested?
- Virtual reality group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 15 Jan 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being the first to undergo noninvasive urodynamics;
- Agreeing to participate in the study;
- Being between the ages of 30-50.
Who cannot join
- Having had a urodynamic test before;
- Being on antidepressants or anxiolytics;
- Having communication and cooperation problems;
- Having visual or balance disorders.
About this study
Official title: The Effect of Virtual Reality During Non-Invasive Urodynamics on Patients' Vital Signs, Anxiety, and Satisfaction Levels
Study Topic
This research aims to evaluate the effects of virtual reality (VR) application during noninvasive urodynamics on patients' vital signs, anxiety, and satisfaction levels.
Read more
Significance of the Problem
Urodynamic studies are essential diagnostic methods for assessing lower urinary tract functions.
However, they often cause discomfort, pain, and high levels of anxiety in patients.
This not only negatively affects the patient experience but also creates uncertainty in clinical decision-making.
Previous studies have shown that nursing interventions such as music therapy, aromatherapy, and heating pads effectively reduce anxiety.
Recently, VR technology has emerged as a promising tool to distract patients, thereby reducing pain and anxiety.
Aim of the Study
To investigate the effects of VR application during noninvasive urodynamics on:
Vital signs,
Anxiety,
Comfort, and
Patient satisfaction.
Methodology
Design: Single-center, randomized controlled clinical trial.
Setting/Duration: Urology Outpatient Clinic, Ankara Etlik City Hospital, September - December 2025.
Sample: Based on power analysis, at least 26 patients per group; total minimum of 52 participants.
Inclusion criteria: 18-50 years old, undergoing noninvasive urodynamics for the first time, voluntary participation.
Exclusion criteria: Previous urodynamics, use of anxiolytics/antidepressants, communication/vision/balance impairments.
Randomization: Block randomization (block size 6).
Data Collection Tools
Descriptive Characteristics Form
State-Trait Anxiety Inventory (STAI)
Vital Signs and Urodynamic Parameters Monitoring Form
Patient Satisfaction and Comfort Assessment (Visual Analog Scale - VAS)
VR Application Satisfaction Form
Interventions
VR Group: During uroflowmetry, patients will experience a 360° virtual hygienic and spacious bathroom environment via VR goggles.
Control Group: Routine clinical practice only, with standard pre-procedure information.
Data Analysis
Data will be analyzed using SPSS 21.0.
Normality will be tested with Kolmogorov-Smirnov.
Between-group differences will be assessed using Independent Samples t-test or Mann-Whitney U test, as appropriate.
Statistical significance will be set at p < 0.05.
Ethical Considerations
Ethical approval and hospital permission were obtained.
Informed consent will be collected from all participants prior to data collection.
Read the detailed description
Background:
Urodynamic studies are essential diagnostic tools for evaluating lower urinary tract function. However, they often cause discomfort, pain, and anxiety, which may negatively affect patient experience and the accuracy of clinical results. Non-pharmacological interventions such as music therapy and aromatherapy have been shown to reduce anxiety. Virtual reality (VR) is a promising new approach that provides immersive distraction and has demonstrated benefits in clinical care, but its use in urodynamic testing remains limited.
Objective:
To evaluate the effects of VR application during non-invasive urodynamics on:
Vital signs
Anxiety
Comfort
Patient satisfaction
Design and Setting:
Single-center, randomized controlled clinical trial. Location: Urology Outpatient Clinic, Ankara Etlik City Hospital. Study period: November 2025 - January 2026.
Participants:
Minimum 52 participants (26 per group).
Inclusion criteria: Adults aged 18-50, undergoing non-invasive urodynamics for the first time, voluntary participation.
Exclusion criteria: Previous urodynamics, antidepressant/anxiolytic use, communication problems, visual or balance disorders.
Randomization:
Block randomization (block size = 6).
Interventions:
VR Group: During uroflowmetry, participants will use VR goggles displaying a 360° visualization of a hygienic and spacious bathroom environment.
Control Group: Routine clinical practice only, with standard pre-procedure information.
Measurements and Tools:
Descriptive Characteristics Form
State-Trait Anxiety Inventory (STAI)
Vital Signs and Urodynamic Parameters Monitoring Form
Patient Satisfaction and Comfort Assessment (Visual Analog Scale, VAS)
VR Application Satisfaction Form
Data Collection and Analysis:
Assessments conducted before, during, and after urodynamics.
Statistical analyses with SPSS 21.0.
Normality tested with Kolmogorov-Smirnov.
Group comparisons with Independent Samples t-test or Mann-Whitney U test.
Significance level: p < 0.05.
Ethics:
Approved by the Gülhane Research Ethics Committee. Institutional approval obtained. Written informed consent will be collected from all participants.
Expected Contribution:
This trial will provide evidence on the role of VR in reducing anxiety, improving comfort, and enhancing patient satisfaction during urodynamic procedures.
- Conditions
- Urinary Incontinence, Urodynamic Studies, Urodynamics
- Being tested
- Virtual reality group
- Keywords
- Urinary incontinence, urodynamic studies, anxiety, satisfaction
- Medical subject headings
- Urinary Incontinence, 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 groupOther
In the course of noninvasive urodynamic testing, patients will be presented with a 360-degree visualization of a clean and spacious bathroom environment via virtual reality goggles.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | In the course of noninvasive urodynamic testing, patients will be presented with a 360-degree visualization of a clean and spacious bathroom environment via virtual reality goggles. Receives: Other: Virtual reality group |
| Control group | No intervention | The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State)
State Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-State), a 20-item scale ranging from 20 to 80 points. Higher scores indicate higher anxiety. Unit of Measure: points (20-80)
Measured: Baseline and immediately after the procedure
Secondary outcomes (4)
Uroflowmetry Parameters (Qmax, Qavg, voided volume, flow time)
Uroflowmetry parameters including maximum flow rate (Qmax, mL/s), average flow rate (Qavg, mL/s), voided volume (mL), and flow time (seconds) will be recorded during the procedure. Unit of Measure: mL/s; mL; seconds
Measured: During the procedure
Change in Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation)
Vital signs (systolic/diastolic blood pressure in mmHg, heart rate in bpm, respiratory rate in breaths/min, and SpO₂ in %) will be measured before and after the uroflowmetry procedure. Unit of Measure: mmHg, bpm, breaths/min, %
Measured: Baseline and immediately after procedure
Patient Satisfaction Score (Visual Analog Scale - VAS)
Satisfaction will be assessed using a Visual Analog Scale ranging from 0 (no satisfaction) to 10 (highest satisfaction). Unit of Measure: VAS score (0-10)
Measured: Immediately after the procedure
Patient Comfort Score (Visual Analog Scale - VAS)
Comfort will be assessed using a Visual Analog Scale ranging from 0 (no comfort) to 10 (highest comfort). Unit of Measure: VAS score (0-10)
Measured: 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 posted11 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Özden, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277894
- Sponsor's protocol ID
- SagligBilimleriU
- Status last verified
- Nov 2025
- First submitted
- 22 Aug 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared. Supporting information including the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and clinical study report (CSR) will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality During Non-Invasive Urodynamics on Patients' Vital Signs, Anxiety, and Satisfaction Levels
- ClinicalTrials.gov ID
- NCT07277894
- Acronym / sponsor ID
- SagligBilimleriU
- Conditions
- Urinary Incontinence, Urodynamic Studies, Urodynamics
- Keywords
- Urinary incontinence, urodynamic studies, anxiety, satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 11 Dec 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.
Study Topic
This research aims to evaluate the effects of virtual reality (VR) application during noninvasive urodynamics on patients' vital signs, anxiety, and satisfaction levels.
Significance of the Problem
Urodynamic studies are essential diagnostic methods for assessing lower urinary tract functions.
However, they often cause discomfort, pain, and high levels of anxiety in patients.
This not only negatively affects the patient experience but also creates uncertainty in clinical decision-making.
Previous studies have shown that nursing interventions such as music therapy, aromatherapy, and heating pads effectively reduce anxiety.
Recently, VR technology has emerged as a promising tool to distract patients, thereby reducing pain and anxiety.
Aim of the Study
To investigate the effects of VR application during noninvasive urodynamics on:
Vital signs,
Anxiety,
Comfort, and
Patient satisfaction.
Methodology
Design: Single-center, randomized controlled clinical trial.
Setting/Duration: Urology Outpatient Clinic, Ankara Etlik City Hospital, September - December 2025.
Sample: Based on power analysis, at least 26 patients per group; total minimum of 52 participants.
Inclusion criteria: 18-50 years old, undergoing noninvasive urodynamics for the first time, voluntary participation.
Exclusion criteria: Previous urodynamics, use of anxiolytics/antidepressants, communication/vision/balance impairments.
Randomization: Block randomization (block size 6).
Data Collection Tools
Descriptive Characteristics Form
State-Trait Anxiety Inventory (STAI)
Vital Signs and Urodynamic Parameters Monitoring Form
Patient Satisfaction and Comfort Assessment (Visual Analog Scale - VAS)
VR Application Satisfaction Form
Interventions
VR Group: During uroflowmetry, patients will experience a 360° virtual hygienic and spacious bathroom environment via VR goggles.
Control Group: Routine clinical practice only, with standard pre-procedure information.
Data Analysis
Data will be analyzed using SPSS 21.0.
Normality will be tested with Kolmogorov-Smirnov.
Between-group differences will be assessed using Independent Samples t-test or Mann-Whitney U test, as appropriate.
Statistical significance will be set at p < 0.05.
Ethical Considerations
Ethical approval and hospital permission were obtained.
Informed consent will be collected from all participants prior to data collection.
Detailed description
Background:
Urodynamic studies are essential diagnostic tools for evaluating lower urinary tract function. However, they often cause discomfort, pain, and anxiety, which may negatively affect patient experience and the accuracy of clinical results. Non-pharmacological interventions such as music therapy and aromatherapy have been shown to reduce anxiety. Virtual reality (VR) is a promising new approach that provides immersive distraction and has demonstrated benefits in clinical care, but its use in urodynamic testing remains limited.
Objective:
To evaluate the effects of VR application during non-invasive urodynamics on:
Vital signs
Anxiety
Comfort
Patient satisfaction
Design and Setting:
Single-center, randomized controlled clinical trial. Location: Urology Outpatient Clinic, Ankara Etlik City Hospital. Study period: November 2025 - January 2026.
Participants:
Minimum 52 participants (26 per group).
Inclusion criteria: Adults aged 18-50, undergoing non-invasive urodynamics for the first time, voluntary participation.
Exclusion criteria: Previous urodynamics, antidepressant/anxiolytic use, communication problems, visual or balance disorders.
Randomization:
Block randomization (block size = 6).
Interventions:
VR Group: During uroflowmetry, participants will use VR goggles displaying a 360° visualization of a hygienic and spacious bathroom environment.
Control Group: Routine clinical practice only, with standard pre-procedure information.
Measurements and Tools:
Descriptive Characteristics Form
State-Trait Anxiety Inventory (STAI)
Vital Signs and Urodynamic Parameters Monitoring Form
Patient Satisfaction and Comfort Assessment (Visual Analog Scale, VAS)
VR Application Satisfaction Form
Data Collection and Analysis:
Assessments conducted before, during, and after urodynamics.
Statistical analyses with SPSS 21.0.
Normality tested with Kolmogorov-Smirnov.
Group comparisons with Independent Samples t-test or Mann-Whitney U test.
Significance level: p < 0.05.
Ethics:
Approved by the Gülhane Research Ethics Committee. Institutional approval obtained. Written informed consent will be collected from all participants.
Expected Contribution:
This trial will provide evidence on the role of VR in reducing anxiety, improving comfort, and enhancing patient satisfaction during urodynamic procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Other: Virtual reality groupIn the course of noninvasive urodynamic testing, patients will be presented with a 360-degree visualization of a clean and spacious bathroom environment via virtual reality goggles. |
| Control group | No intervention | –The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being the first to undergo noninvasive urodynamics;
- Agreeing to participate in the study;
- Being between the ages of 30-50.
Key exclusion criteria (4 listed)
- Having had a urodynamic test before;
- Being on antidepressants or anxiolytics;
- Having communication and cooperation problems;
- Having visual or balance disorders.
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 groupIn the course of noninvasive urodynamic testing, patients will be presented with a 360-degree visualization of a clean and spacious bathroom environment via virtual reality goggles. | Other | virtual reality group |
Primary outcome
Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State)
Time frame: Baseline and immediately after the procedure
State Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-State), a 20-item scale ranging from 20 to 80 points. Higher scores indicate higher anxiety. Unit of Measure: points (20-80)
4 secondary outcomes
Uroflowmetry Parameters (Qmax, Qavg, voided volume, flow time)
Time frame: During the procedure
Change in Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation)
Time frame: Baseline and immediately after procedure
Patient Satisfaction Score (Visual Analog Scale - VAS)
Time frame: Immediately after the procedure
Patient Comfort Score (Visual Analog Scale - VAS)
Time frame: Immediately after the procedure
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 11 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared. Supporting information including the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and clinical study report (CSR) will also be made available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality group in people with Urinary Incontinence and Urodynamic Studies, run by Saglik Bilimleri Universitesi.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State) (time frame: Baseline and immediately after the procedure). 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 11 Dec 2025.