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

Anxiety Clinical Trial

— VRFORANXIETY  

Official title:

Virtual Reality (VR)-Based Intervention to Improve Pre-operative Anxiety in Patients Undergoing Elective Oocyte Cryopreservation: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280222
• Other study ID #: VR FOR ANXIETY-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Hadassah Medical Organization
• Contact: Anat Hershko-Klement, M.D
• Phone: +972549170084
• Email: anat.klement[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 ?ashing 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah mound scopus IVF unit	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs	Blood pressure (systolic+ diastolic levels)	Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Primary	Vital signs	Heart rate (Beats per minute)	Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Primary	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)
Primary	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)