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

February 25, 2024 updated by: SUISSA COHEN YAEL, Hadassah Medical Organization

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah mound scopus IVF unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Patients in the interventional group will watch 20-minute scenery movies in the VR instrument before entering the oocyte retrieval procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs
Time Frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Blood pressure (systolic+ diastolic levels)
Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Vital signs
Time Frame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Heart rate (Beats per minute)
Up to 8 hours from admission. (Admission, pre-procedural, discharge)
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.
Up to 8 hours from admission. (Admission, pre-procedural, discharge)
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.
Up to 8 hours from admission. (Admission, pre-procedural, discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR FOR ANXIETY-HMO-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on The VR instrument - Oculus Quest 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe