Virtual Reality Headsets Reduce Anxiety During Urodynamic TestsNCT06905665
The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG
A study testing Virtual reality group in people with Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized trial tested if VR headsets reduce anxiety during urodynamic tests. First-time adult patients (18-70) were split into VR (nature videos) and control groups, with anxiety measured before and after using standard surveys. Results will show if VR offers drug-free anxiety relief for this procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests
- 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
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 20 Sep 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18-70 undergoing urodynamic testing for the first time
- Individuals with the mental capacity to decide whether they wish to participate in the study
- No communication difficulties
Who cannot join
- Use of any psychiatric medication
- Individuals with visual impairments
- Individuals with speech disorders
- Individuals experiencing complications during the urodynamic procedure
- Withdrawal from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon Kanuni Education and Research Hospital
Trabzon, Turkey, 38000
About this study
Official title: The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG; a PROSPECTİVE, RANDOMIZED CONTROLLED STUDY
This randomized trial tested if VR headsets reduce anxiety during urodynamic tests. First-time adult patients (18-70) were split into VR (nature videos) and control groups, with anxiety measured before and after using standard surveys. Results will show if VR offers drug-free anxiety relief for this procedure.
Read the detailed description
This study was designed as a pre-test and post-test randomized controlled trial to determine the effect of VR headset use on anxiety levels in patients undergoing urodynamic testing. Patients scheduled for urodynamic evaluation in our clinic between April 20, 2023, and June 30, 2023, were included in the study. Participants were randomized into two groups-VR and control-using the computer-based Research Randomizer program. Ethical approval for the study was obtained from the local ethics committee (2023/17).
Inclusion Criteria:
- Individuals aged 18-70 undergoing urodynamic testing for the first time
- Individuals with the mental capacity to decide whether they wish to participate in the study
- No communication difficulties
Exclusion Criteria:
- Use of any psychiatric medication
- Individuals with visual impairments
- Individuals with speech disorders
- Individuals experiencing complications during the urodynamic procedure
- Withdrawal from the study For the VR group, the purpose of the study was explained before the procedure, and both verbal and written informed consent were obtained. Additionally, patients were provided with detailed information about how to use the headset, what to expect, and the content of the video before viewing. Data collection forms and the State-Trait Anxiety Inventory (STAI I-II) were completed using a face-to-face interview technique before the procedure.
During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes), patients watched pre-recorded 360-degree nature scenery videos via YouTube. Care was taken to exclude any visual or auditory stimuli that could influence urodynamic results (e.g., sounds of water, rivers, waterfalls, streams). Patients were informed that they could remove the headset at any time if they experienced discomfort.
For the control group, no additional interventions were applied beyond the routine procedure. Before the procedure, participants completed the Data Collection Form and the State-Trait Anxiety Inventory (STAI I-II).
The Data Collection Form included 14 questions designed to gather demographic and clinical characteristics such as gender, height, weight, age, marital status, education level, employment status, smoking and alcohol consumption, income level, presence of chronic diseases, history of previous surgeries, history of prior urodynamic testing, coping strategies used during anxiety, and prior knowledge of the urodynamic procedure, including the source of their information. In addition to these questions, the VR group was also asked whether they would prefer using a VR headset for future urodynamic procedures and whether they would recommend it to other patients.
State-Trait Anxiety Inventory (STAI I-II)
The STAI I-II was developed by Spielberger et al. in 1970 to separately measure state and trait anxiety levels. This inventory consists of two separate scales, each containing 20 items, with some questions assessing negative emotions and others evaluating positive emotions. The STAI-I measures state anxiety by asking individuals to rate their anxiety level at a specific time under specific conditions using a four-point Likert scale:
- = Not at all
- = Somewhat
- = Very much
- = Completely The total score represents the individual's state anxiety level at that moment.
The STAI-II assesses trait anxiety by evaluating how individuals generally feel, independent of their current situation. Participants rate the frequency of their anxiety using the following scale:
- = Almost never
- = Sometimes
- = Often
- = Almost always Each scale consists of 20 questions, with scores ranging from 20 to 80, where higher scores indicate higher anxiety levels.18,19 At the end of the procedure, participants in both groups completed the STAI Form I again. Pre- and post-procedure scores were compared between the two groups.
- Being tested
- Virtual reality group
- Keywords
- Virtual reality, urodynamics, anxiety, lower urinary tract dysfunction
- 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
For the VR group, the purpose of the study was explained before the procedure, and both verbal and written informed consent were obtained. Additionally, patients were provided with detailed information about how to use the headset, what to expect, and the content of the video before viewing. Data collection forms and the State-Trait Anxiety Inventory (STAI I-II) were completed using a face-to-face interview technique before the procedure.During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes),
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | For the control group, no additional interventions were applied beyond the routine procedure. Before the procedure, participants completed the Data Collection Form and the State-Trait Anxiety Inventory (STAI I-II).
The Data Collection Form included 14 questions designed to gather demographic and clinical characteristics such as gender, height, weight, age, marital status, education level, employment status, smoking and alcohol consumption, income level, presence of chronic diseases, history of previous surgeries, history of prior urodynamic testing, coping strategies used during anxiety, and prior knowledge of the urodynamic procedure, including the source of their information Receives: Device: Virtual reality group |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI I-II)
The STAI I-II was developed by Spielberger et al. in 1970 to separately measure state and trait anxiety levels. This inventory consists of two separate scales, each containing 20 items, with some questions assessing negative emotions and others evaluating positive emotions. The STAI-I measures state anxiety by asking individuals to rate their anxiety level at a specific time under specific conditions using a four-point Likert scale:
- = Not at all
- = Somewhat
- = Very much
- = Completely The total score represents the individual's state anxiety level at that moment.
The STAI-II assesses trait anxiety by evaluating how individuals generally feel, independent of their current situation. Participants rate the frequency of their anxiety using the following scale:
- = Almost never
- = Sometimes
- = Often
- = Almost always Each scale consists of 20 questions, with scores ranging from 20 to 80, where higher scores indicate higher anxiety levels.
Measured: 1 (one) day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start20 Apr 2023
- Primary completion20 Jun 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual Reality Headsets Reduce Anxiety During Urodynamic TestsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes), patients watched pre-recorded 360-degree nature scenery videos via YouTube. Care was taken to exclude any visual or auditory stimuli that could influence urodynamic results (e.g., sounds of water, rivers, waterfalls, streams). Patients were informed that they could remove the headset at any time if they experienced discomfort.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Seyis SİBAL, Trabzon Kanuni Education and Research Hospital
- Investigators
- Nurten S SİBAL, Nurse, Principal investigator, Avrasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905665
- Sponsor's protocol ID
- E-23618724-000-213048010
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't have a URL address
Publications
Sibal NS, Sibal I, Aksoy HZ, Aydin HR, Ozoran Y, Sekerci CA. The Effect of Virtual Reality Headset Use on Anxiety Levels During Urodynamic Testing: A Prospective, Randomized Controlled Study. Urology. 2025 Dec;206:48-55. doi: 10.1016/j.urology.2025.08.002. Epub 2025 Aug 6.
PubMed 40780518
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG; a PROSPECTİVE, RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT06905665
- Acronym / sponsor ID
- E-23618724-000-213048010
- Keywords
- Virtual reality, urodynamics, anxiety, lower urinary tract dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 1 Apr 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 trial tested if VR headsets reduce anxiety during urodynamic tests. First-time adult patients (18-70) were split into VR (nature videos) and control groups, with anxiety measured before and after using standard surveys. Results will show if VR offers drug-free anxiety relief for this procedure.
Detailed description
This study was designed as a pre-test and post-test randomized controlled trial to determine the effect of VR headset use on anxiety levels in patients undergoing urodynamic testing. Patients scheduled for urodynamic evaluation in our clinic between April 20, 2023, and June 30, 2023, were included in the study. Participants were randomized into two groups-VR and control-using the computer-based Research Randomizer program. Ethical approval for the study was obtained from the local ethics committee (2023/17).
Inclusion Criteria:
- Individuals aged 18-70 undergoing urodynamic testing for the first time
- Individuals with the mental capacity to decide whether they wish to participate in the study
- No communication difficulties
Exclusion Criteria:
- Use of any psychiatric medication
- Individuals with visual impairments
- Individuals with speech disorders
- Individuals experiencing complications during the urodynamic procedure
- Withdrawal from the study For the VR group, the purpose of the study was explained before the procedure, and both verbal and written informed consent were obtained. Additionally, patients were provided with detailed information about how to use the headset, what to expect, and the content of the video before viewing. Data collection forms and the State-Trait Anxiety Inventory (STAI I-II) were completed using a face-to-face interview technique before the procedure.
During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes), patients watched pre-recorded 360-degree nature scenery videos via YouTube. Care was taken to exclude any visual or auditory stimuli that could influence urodynamic results (e.g., sounds of water, rivers, waterfalls, streams). Patients were informed that they could remove the headset at any time if they experienced discomfort.
For the control group, no additional interventions were applied beyond the routine procedure. Before the procedure, participants completed the Data Collection Form and the State-Trait Anxiety Inventory (STAI I-II).
The Data Collection Form included 14 questions designed to gather demographic and clinical characteristics such as gender, height, weight, age, marital status, education level, employment status, smoking and alcohol consumption, income level, presence of chronic diseases, history of previous surgeries, history of prior urodynamic testing, coping strategies used during anxiety, and prior knowledge of the urodynamic procedure, including the source of their information. In addition to these questions, the VR group was also asked whether they would prefer using a VR headset for future urodynamic procedures and whether they would recommend it to other patients.
State-Trait Anxiety Inventory (STAI I-II)
The STAI I-II was developed by Spielberger et al. in 1970 to separately measure state and trait anxiety levels. This inventory consists of two separate scales, each containing 20 items, with some questions assessing negative emotions and others evaluating positive emotions. The STAI-I measures state anxiety by asking individuals to rate their anxiety level at a specific time under specific conditions using a four-point Likert scale:
- = Not at all
- = Somewhat
- = Very much
- = Completely The total score represents the individual's state anxiety level at that moment.
The STAI-II assesses trait anxiety by evaluating how individuals generally feel, independent of their current situation. Participants rate the frequency of their anxiety using the following scale:
- = Almost never
- = Sometimes
- = Often
- = Almost always Each scale consists of 20 questions, with scores ranging from 20 to 80, where higher scores indicate higher anxiety levels.18,19 At the end of the procedure, participants in both groups completed the STAI Form I again. Pre- and post-procedure scores were compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes), patients watched pre-recorded 360-degree nature scenery videos via YouTube. Care was taken to exclude any visual or auditory stimuli that could influence urodynamic results (e.g., sounds of water, rivers, waterfalls, streams). Patients were informed that they could remove the headset at any time if they experienced discomfort.
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Device: Virtual reality groupFor the control group, no additional interventions were applied beyond the routine procedure. Before the procedure, participants completed the Data Collection Form and the State-Trait Anxiety Inventory (STAI I-II). The Data Collection Form included 14 questions designed to gather demographic and clinical characteristics such as gender, height, weight, age, marital status, education level, employment status, smoking and alcohol consumption, income level, presence of chronic diseases, history of previous surgeries, history of prior urodynamic testing, coping strategies used during anxiety, and prior knowledge of the urodynamic procedure, including the source of their information |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18-70 undergoing urodynamic testing for the first time
- Individuals with the mental capacity to decide whether they wish to participate in the study
- No communication difficulties
Key exclusion criteria (5 listed)
- Use of any psychiatric medication
- Individuals with visual impairments
- Individuals with speech disorders
- Individuals experiencing complications during the urodynamic procedure
- Withdrawal 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 groupFor the VR group, the purpose of the study was explained before the procedure, and both verbal and written informed consent were obtained. Additionally, patients were provided with detailed information about how to use the headset, what to expect, and the content of the video before viewing. Data collection forms and the State-Trait Anxiety Inventory (STAI I-II) were completed using a face-to-face interview technique before the procedure.During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes), | Device | control group |
Primary outcome
State-Trait Anxiety Inventory (STAI I-II)
Time frame: 1 (one) day
The STAI I-II was developed by Spielberger et al. in 1970 to separately measure state and trait anxiety levels. This inventory consists of two separate scales, each containing 20 items, with some questions assessing negative emotions and others evaluating positive emotions. The STAI-I measures state anxiety by asking individuals to rate their anxiety level at a specific time under specific conditions using a four-point Likert scale: 1. = Not at all 2. = Somewhat 3. = Very much 4. = Completely The total score represents the individual's state anxiety level at that moment. The STAI-II assesses trait anxiety by evaluating how individuals generally feel, independent of their current situation. Participants rate the frequency of their anxiety using the following scale: 1. = Almost never 2. = Sometimes 3. = Often 4. = Almost always Each scale consists of 20 questions, with scores ranging from 20 to 80, where higher scores indicate higher anxiety levels.
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 1 Apr 2025.
- Derived from this study: PubMed 40780518Sibal NS, Sibal I, Aksoy HZ, Aydin HR, Ozoran Y, Sekerci CA. The Effect of Virtual Reality Headset Use on Anxiety Levels During Urodynamic Testing: A Prospective, Randomized Controlled Study. Urology. 2025 Dec;206:48-55. doi: 10.1016/j.urology.2025.08.002. Epub 2025 Aug 6.
- Individual participant dataSharing planned: No. I don't have a URL address
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.
Nurten S SİBAL, Nurse principal investigator
Avrasya University
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 Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests, run by Trabzon Kanuni Education and Research Hospital 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 3 inclusion and 5 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 1 Apr 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?
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?
State-Trait Anxiety Inventory (STAI I-II) (time frame: 1 (one) day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905665, which also lists 1 linked publication.
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 1 Apr 2025.