EndometriosisVR Endo TVUNCT07328061
Virtual Reality for Anxiety and Pain Management in Transvaginal Ultrasound for Endometriosis
A study testing Virtual reality - based distraction in people with Endometriosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Virtual reality - based distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Dec 2023to 20 Aug 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 50 years.
- Confirmed or suspected diagnosis of endometriosis.
- Scheduled to undergo transvaginal ultrasound examination.
- Ability to understand the study procedures and independently complete study questionnaires.
- Provided written informed consent.
Who cannot join
- History of epilepsy or seizure disorders.
- History of migraines.
- Visual or hearing impairment.
- Diagnosed anxiety disorders.
- Claustrophobia.
- Current symptoms of dizziness or nausea.
- Active respiratory tract infection.
- Any contraindication to transvaginal ultrasound examination.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Endometriosis Center, Sheba Medical Center
Ramat Gan, Central District
About this study
Official title: Effect of Virtual Reality on Anxiety and Pain During Trans-vaginal Ultrasound for Endometriosis: A Prospective Randomized Controlled Study.
The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis.
Participants, women undergoing TVUS for endometriosis will be randomly assigned to either VR distraction group (VR-TVUS) or a standard examination group (control).
Anxiety and pain levels will be assessed immediately before and after the TVUS.
- Conditions
- Endometriosis
- Being tested
- Virtual reality - based distraction
- Keywords
- Virtual reality, VR distraction, Transvaginal Ultrasound, TVUS, Anxiety, Pain
- Medical subject headings
- Endometriosis, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality - based distractionBehavioural
Participants use an immersive virtual reality headset during TVUS. The intervention consists of immersive three-dimensional (3D) VR distraction delivered a head-mounted display, allowing participants to engage with a computer-simulated virtual environment, with or without guided audio based mindfulness relaxation techniques. The intervention is designed to reduce pain and anxiety during US examination. Each session lasts approximately 10-15 minutes, and may include calming music or guided meditation audio
| Study group | Role | What they receive |
|---|---|---|
| VR- TVUS Group | Experimental | Participants undergo TVUS while using immersive virtual reality distraction Receives: Behavioral: Virtual reality - based distraction |
| Contro Group - Standard TVUS | No intervention | Participants undergo standard TVUS, without virtual reality or any additional distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating
Anxiety levels are assessed using the State Anxiety Inventory (STAI-S). It includes 20 items such as "I feel calm " and "I am tense ". Participates were instructed to circle the number that best describes how they felt at that moment from 1 to 4 (from "Not at all" to "Very much so"). The STAI-S questionnaire is scored by summing the responses to the individual items and the possible scores ranges from 20 to 80, where 20-37 refers to "no or low anxiety", 38-44 to "moderate anxiety", and 45-80 to "high anxiety" (45-80). The outcome measure is the change in STAI-S score from before to immediately after the TVUS examination
Measured: From immediately before the TVUS to immediately after completion of the examination.
Secondary outcomes (2)
Change in pain intensity measured by Visual Analog scale (VAS)
Pain intensity is assessed using a VAS . VAS is a self-reported measure of pain expressed as a number on a continuum between 1 ("no pain") and 10 ("worst pain").
Measured: From immediately before the TVUS to immediately after completion of the examination.
Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS
Heart rate and blood pressure level are measured as objective measures of emotional distress and pain.
Measured: The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start10 Dec 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants Are randomized to undergo either transvaginal ultrasound with virtual reality distraction or standard transvaginal ultrasound without virtual reality. Each participant is assigned to a single study arm for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Zajicek, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328061
- Sponsor's protocol ID
- 0142-23-SMC
- Acronym
- VR Endo TVU
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Anxiety and Pain During Trans-vaginal Ultrasound for Endometriosis: A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07328061
- Acronym / sponsor ID
- VR Endo TVU / 0142-23-SMC
- Conditions
- Endometriosis
- Keywords
- Virtual reality, VR distraction, Transvaginal Ultrasound, TVUS, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 8 Jan 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.
The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis.
Participants, women undergoing TVUS for endometriosis will be randomly assigned to either VR distraction group (VR-TVUS) or a standard examination group (control).
Anxiety and pain levels will be assessed immediately before and after the TVUS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants Are randomized to undergo either transvaginal ultrasound with virtual reality distraction or standard transvaginal ultrasound without virtual reality. Each participant is assigned to a single study arm for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| VR- TVUS Group | Experimental | Behavioral: Virtual reality - based distractionParticipants undergo TVUS while using immersive virtual reality distraction |
| Contro Group - Standard TVUS | No intervention | –Participants undergo standard TVUS, without virtual reality or any additional distraction intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18 to 50 years.
- Confirmed or suspected diagnosis of endometriosis.
- Scheduled to undergo transvaginal ultrasound examination.
- Ability to understand the study procedures and independently complete study questionnaires.
- Provided written informed consent.
Key exclusion criteria (8 listed)
- History of epilepsy or seizure disorders.
- History of migraines.
- Visual or hearing impairment.
- Diagnosed anxiety disorders.
- Claustrophobia.
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 - based distractionParticipants use an immersive virtual reality headset during TVUS. The intervention consists of immersive three-dimensional (3D) VR distraction delivered a head-mounted display, allowing participants to engage with a computer-simulated virtual environment, with or without guided audio based mindfulness relaxation techniques. The intervention is designed to reduce pain and anxiety during US examination. Each session lasts approximately 10-15 minutes, and may include calming music or guided meditation audio | Behavioural | VR- TVUS Group |
Primary outcome
Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating
Time frame: From immediately before the TVUS to immediately after completion of the examination.
Anxiety levels are assessed using the State Anxiety Inventory (STAI-S). It includes 20 items such as "I feel calm " and "I am tense ". Participates were instructed to circle the number that best describes how they felt at that moment from 1 to 4 (from "Not at all" to "Very much so"). The STAI-S questionnaire is scored by summing the responses to the individual items and the possible scores ranges from 20 to 80, where 20-37 refers to "no or low anxiety", 38-44 to "moderate anxiety", and 45-80 to "high anxiety" (45-80). The outcome measure is the change in STAI-S score from before to immediately after the TVUS examination
2 secondary outcomes
Change in pain intensity measured by Visual Analog scale (VAS)
Time frame: From immediately before the TVUS to immediately after completion of the examination.
Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS
Time frame: The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination.
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 8 Jan 2026.
- Individual participant dataSharing planned: No
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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 - based distraction in people with Endometriosis, run by Sheba Medical Center at 1 site in Israel.
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 8 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 8 Jan 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 Israel. 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?
Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating (time frame: From immediately before the TVUS to immediately after completion of the examination.). 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 8 Jan 2026.