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RecruitingNCT06280222VRFORANXIETYUpdated Feb 28, 2024

The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation.

An interventional study of The VR instrument - Oculus Quest 2 in Anxiety, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
Female
01

Study summary

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:

  1. No intervention (routine management).
  2. 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.

02

Conditions studied

  • Anxiety

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients before egg retrieval for social reasons (elective egg freezing)

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Risk for seizures
    2. Sensitivity to flashing light/motion
    3. Predisposing to nausea/dizziness (vertigo, etc.) Any injury to the eyes/face/neck that would limit the use of the hardware, including blindness.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Routine management

    Usual care of patients prior to a surgical procedure : oocyte retrieval

  • Experimental
    Virtual reality management

    20 minutes of scenery VR movies prior to the surgical procedure (oocyte retrieval)

    Device: The VR instrument - Oculus Quest 2

Interventions

  • DeviceThe VR instrument - Oculus Quest 2

    Patients in the interventional group will watch 20-minute scenery movies in the VR instrument before entering the oocyte retrieval procedure.

06

What researchers measure

Primary outcomes

  1. Vital signs

    Blood pressure (systolic+ diastolic levels)

    Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)

  2. Vital signs

    Heart rate (Beats per minute)

    Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)

  3. VAS (visual-analogue scale)

    VAS anxiety score (1-10), Higher levels indicate higher anxiety levels.

    Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)

  4. 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.

    Time frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)

07

Study locations

1 of 1 sites recruiting
  • Hadassah mound scopus IVF unit
    Jerusalem, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06280222
Lead sponsor
Hadassah Medical Organization
Responsible party
SUISSA COHEN YAEL (Doctor, MD, Principal investigator, Hadassah Medical Organization) — Principal investigator
First posted
Feb 28, 2024
Start date
Nov 15, 2023
Primary completion
Nov 15, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Feb 28, 2024

Study contacts

Anat Hershko-Klement, M.D
Contact
anat.klement@gmail.com
+972549170084

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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