AnxietyVRFORANXIETYNCT06280222
The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation.
A study testing The VR instrument - Oculus Quest 2 in people with Anxiety, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level . Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- The VR instrument - Oculus Quest 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Nov 2023to 1 Feb 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients before egg retrieval for social reasons (elective egg freezing)
Who cannot join
- Use of any medications for pain relief/ anti -anxiety /anti -depressants medication generally or prior to the intervention
- If suffers from any condition that Use of VR is not recommended:
- Risk for seizures
- Sensitivity to flashing light/motion
- Predisposing to nausea/dizziness (vertigo, etc.) Any injury to the eyes/face/neck that would limit the use of the hardware, including blindness.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah mound scopus IVF unit
Jerusalem
Anat Hershko-Klement, M.D, +972549170084, anat.klement@gmail.com
About this study
Official title: Virtual Reality (VR)-Based Intervention to Improve Pre-operative Anxiety in Patients Undergoing Elective Oocyte Cryopreservation: a Randomized Clinical Trial
A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .
Read the detailed description
Eligible women, undergoing elective egg freezing, will be offered to participate in the study, and sign a consent form.
The patients will be randomized into 2 groups:
- No intervention (routine management).
- Exposure to scenery video, as a VR (virtual reality) session.
All women will be addressed prior to the procedure, while they are waiting, and upon consent will be asked to state their VAS (visual analogue scale) anxiety score and to fill the STAI (The State-Trait Anxiety Inventory questionnaire.) Vital signs (Heart rate, Blood pressure) will be recorded upon arrival.
Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again. vital signs will be recorded again.
After recovery all women will fill the STAI questionnaire, VAS score and vital signs before they will be discharged.
- Conditions
- Anxiety
- Being tested
- The VR instrument - Oculus Quest 2
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The VR instrument - Oculus Quest 2Device
Patients in the interventional group will watch 20-minute scenery movies in the VR instrument before entering the oocyte retrieval procedure.
| Study group | Role | What they receive |
|---|---|---|
| Routine management | No intervention | Usual care of patients prior to a surgical procedure : oocyte retrieval |
| Virtual reality management | Experimental | 20 minutes of scenery VR movies prior to the surgical procedure (oocyte retrieval) Receives: Device: The VR instrument - Oculus Quest 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Blood pressure (systolic+ diastolic levels)
Measured: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Vital signs
Heart rate (Beats per minute)
Measured: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
VAS (visual-analogue scale)
VAS anxiety score (1-10), Higher levels indicate higher anxiety levels.
Measured: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
State and Trait Anxiety (STAI) Score
The patient's anxiety levels will be assessed using the STAI questionnaire, higher numbers in the questionnaire indicate higher anxiety levels. Levels up to 30 indicate low anxiety, between 30-45 moderate anxiety, more than 46 high anxiety levels.
Measured: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Nov 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
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 AnxietyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SUISSA COHEN YAEL, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280222
- Sponsor's protocol ID
- VR FOR ANXIETY-HMO-CTIL
- Acronym
- VRFORANXIETY
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suissa-Cohen Y, Frenkel R, Nevo L, Kam HA, Bentov Y, Godin M, Broder EE, Hizkiyahu R, Lazarovits CA, Beharier O, Klement AH. Virtual reality-based intervention to improve pre-operative anxiety in patients undergoing planned oocyte cryopreservation: a randomized clinical trial. J Assist Reprod Genet. 2025 Sep;42(9):2995-3002. doi: 10.1007/s10815-025-03571-w. Epub 2025 Jul 9.
PubMed 40632426
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR)-Based Intervention to Improve Pre-operative Anxiety in Patients Undergoing Elective Oocyte Cryopreservation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06280222
- Acronym / sponsor ID
- VRFORANXIETY / VR FOR ANXIETY-HMO-CTIL
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 28 Feb 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.
A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .
Detailed description
Eligible women, undergoing elective egg freezing, will be offered to participate in the study, and sign a consent form.
The patients will be randomized into 2 groups:
- No intervention (routine management).
- Exposure to scenery video, as a VR (virtual reality) session.
All women will be addressed prior to the procedure, while they are waiting, and upon consent will be asked to state their VAS (visual analogue scale) anxiety score and to fill the STAI (The State-Trait Anxiety Inventory questionnaire.) Vital signs (Heart rate, Blood pressure) will be recorded upon arrival.
Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again. vital signs will be recorded again.
After recovery all women will fill the STAI questionnaire, VAS score and vital signs before they will be discharged.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine management | No intervention | –Usual care of patients prior to a surgical procedure : oocyte retrieval |
| Virtual reality management | Experimental | Device: The VR instrument - Oculus Quest 220 minutes of scenery VR movies prior to the surgical procedure (oocyte retrieval) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients before egg retrieval for social reasons (elective egg freezing)
Key exclusion criteria (5 listed)
- Use of any medications for pain relief/ anti -anxiety /anti -depressants medication generally or prior to the intervention
- If suffers from any condition that Use of VR is not recommended:
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 |
|---|---|---|
| The VR instrument - Oculus Quest 2Patients in the interventional group will watch 20-minute scenery movies in the VR instrument before entering the oocyte retrieval procedure. | Device | Virtual reality management |
Primary outcome
Vital signs
Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Blood pressure (systolic+ diastolic levels)
Vital signs
Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Heart rate (Beats per minute)
VAS (visual-analogue scale)
Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
VAS anxiety score (1-10), Higher levels indicate higher anxiety levels.
State and Trait Anxiety (STAI) Score
Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
The patient's anxiety levels will be assessed using the STAI questionnaire, higher numbers in the questionnaire indicate higher anxiety levels. Levels up to 30 indicate low anxiety, between 30-45 moderate anxiety, more than 46 high anxiety levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40632426Suissa-Cohen Y, Frenkel R, Nevo L, Kam HA, Bentov Y, Godin M, Broder EE, Hizkiyahu R, Lazarovits CA, Beharier O, Klement AH. Virtual reality-based intervention to improve pre-operative anxiety in patients undergoing planned oocyte cryopreservation: a randomized clinical trial. J Assist Reprod Genet. 2025 Sep;42(9):2995-3002. doi: 10.1007/s10815-025-03571-w. Epub 2025 Jul 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The VR instrument - Oculus Quest 2 in people with Anxiety, run by Hadassah Medical Organization 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 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Hershko-Klement, M.D (+972549170084, anat.klement@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital signs (time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)). The study lists 4 primary outcomes in all. 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 NCT06280222, 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 28 Feb 2024.