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

Not Applicable

Recruiting

• Conditions: Anxiety
• Interventions: Device: The VR instrument - Oculus Quest 2

• Registration Number: NCT06280222
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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 Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-12-07
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-11-15
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality management	The VR instrument - Oculus Quest 2	20 minutes of scenery VR movies prior to the surgical procedure (oocyte retrieval)

Primary Outcome Measures

Name	Time	Method
State and Trait Anxiety (STAI) Score	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.
VAS (visual-analogue scale)	Up to 8 hours from admission. (Admission, pre-procedural, discharge)	VAS anxiety score (1-10), Higher levels indicate higher anxiety levels.
Vital signs	Up to 8 hours from admission. (Admission, pre-procedural, discharge)	Heart rate (Beats per minute)

Trial Locations

Locations (1)

Hadassah mound scopus IVF unit; 🇮🇱 Jerusalem, Israel