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

NCT ID: NCT06280222

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-02-01

Brief Summary

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A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .

Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Routine management

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual reality management

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

Group Type EXPERIMENTAL

The VR instrument - Oculus Quest 2

Intervention Type DEVICE

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

Interventions

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The 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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SUISSA COHEN YAEL

Doctor, MD, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah mound scopus IVF unit

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Anat Hershko-Klement, M.D

Role: CONTACT

+972549170084

Facility Contacts

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Anat Hershko-Klement, M.D

Role: primary

+972549170084

References

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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 Jul 9. doi: 10.1007/s10815-025-03571-w. Online ahead of print.

Reference Type DERIVED
PMID: 40632426 (View on PubMed)

Other Identifiers

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VR FOR ANXIETY-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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