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

NCT06280222 | Recruiting

• 1 other identifier: VR FOR ANXIETY-HMO-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (4)

• Vital signs

  Blood pressure (systolic+ diastolic levels)

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

• Vital signs

  Heart rate (Beats per minute)

  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.

  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.

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

Study Arms (2)

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)

Device: The VR instrument - Oculus Quest 2

Interventions

The VR instrument - Oculus Quest 2 DEVICE

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

Virtual reality management

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah mound scopus IVF unit

Jerusalem, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 40632426 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Anat Hershko-Klement, M.D

CONTACT

+972549170084; anat.klement@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, MD, Principal investigator

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: February 28, 2024
• Study Start: November 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: February 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IL (1)