Interest of Virtual Reality in the Management of Anxiety and Pain During Embryo Transfer (ET)

CMC Ambroise Paré12 enrolled

Overview

This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure

Medical interventions often cause pain, distress or anxiety for most patients. The use of music and movies has proven effective in pediatrics. Virtual Reality (VR) is a newer technology that immerses users in a pleasant, three-dimensional environment via a headset. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care. This randomized monocentric trial compares the effect of the use of VR versus without VR during the transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development. The primary outcome will include clinical pregnancy rate and the secondary outcome focuses on the patient's levels of anxiety and stress. Data on the level of anxiety and stress will be collected through questionnaires before and after the procedure. Also, clinical pregnancy, defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity, will be assessed through ultrasons 8 ± 4 weeks after the procedure

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

IVF Stress Anxiety

Interventions

Virtual Reality during Embryo TransferDEVICE

Patients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 10-15 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Will benefit from in vitro Fertilization (IVF or ICSI) * Aged over 18 and under 43, * Attempt Rank 1 or 2 * Requiring a transfer of a single fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development * Having received information and given their consent to participate in accordance with the regulations * Benefiting from a social security scheme or entitled. Exclusion Criteria: * Use of frozen sperm * Use of testicular sperm * Fecundation technique used: IMSI * Early embryo transfer on D2 or D3 * Inability to understand the information given * Under guardianship, under curatorship or under safeguard of justice, * Communication difficulties or neuropsychic disorders, * Current corneal or conjunctival pathologies, * Claustrophobia, * Appearance of nausea in the mountains or at sea, * Regular use of anxiolytics

Locations (1)

Clinique Pierre Cherest

Neuilly-sur-Seine, France

Outcomes

Primary Outcomes

Clinical Pregnancy Rate

Clinical Pregnancy Rate defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity

Time frame: Assessed 12 weeks after embryo transfer

Secondary Outcomes

State and Trait Anxiety Inventory (STAI) questionnaires

The rate of anxiety and stress level before and after embryo transfer, measured by the State and Trait Anxiety Inventory (STAI) StAI-Y1-State ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety) StAI-Y2-Trait ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety)

Time frame: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure

Generalized Anxiety Disorder - 7 (GAD-7) questionnaires

The rate of anxiety and stress level before and after embryo transfer, measured by Generalized Anxiety Disorder - 7 (GAD-7) questionnaires GAD-7 ranging from 0 to 21 (0= No or Minimal Stress, 21= Worst Possible Stress)

Time frame: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure

Data from ClinicalTrials.gov

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