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

Hadassah Medical Organization30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hadassah mound scopus IVF unit

Jerusalem, Israel

RECRUITING

Outcomes

Primary Outcomes

Vital signs

Blood pressure (systolic+ diastolic levels)

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

Vital signs

Heart rate (Beats per minute)

Time frame: 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.

Time frame: 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.

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

Central Contacts

Anat Hershko-Klement, M.D

CONTACT

+972549170084 anat.klement@gmail.com

Data from ClinicalTrials.gov

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