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

Study Overview
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Brief Summary
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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

Detailed Description
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Medical interventions that they often cause pain, distress or anxiety for most patients. The use of music and movies has been shown to be effective in pediatrics. Actually, Virtual Reality (VR) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. 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 vs without VR during blastocyst transfer at day 5 on the pregnancy rate and the level of anxiety and stress of the patient. Data on the level of anxiety and stress will be collected via quiz before and after the procedure. Also, pregnancy rate will be assessed 10 days after the procedure by β_HCG assessment.

Official Title
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Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)

Conditions
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IVF, Stress, Anxiety

Intervention / Treatment
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* Device: Virtual Reality during Embryo Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Will benefit from in vitro Fertilization (IVF or ICSI) Aged over 18 and under 43, Attempt Rank 1 or 2 To benefit from a transfer of a single fresh blastocyst on the 5th day of development Fresh embryo transfer 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, Taking an anxiolytic or a sleeping pill within 12 hours prior to randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ET on D5 without RV<br>Patients who will be randomized to the control group will be waiting for the embryo transfer procedure according to the usual service protocol. | |
| Experimental: ET on D5 with RV<br>The transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure | Device: Virtual Reality during Embryo Transfer<br>* Patients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 30 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | The rate of pregnancy , defined by a plasma beta-HCG dosage greater than 1000 UI , 10 days after the transfer, and sonographic evidence of a gestational sac on the echography of 6 weeks | Assessed 4 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 60 minutes before ET 2) ET day, 10 minutes after ET procedure | 
| Beck Depression Index (C-BDI-II) questionnaires | The rate of anxiety and stress level before and after embryo transfer, measured by Beck Depression Index (C-BDI-II) questionnaires BDI-II ranging from 0 to 63 (0= No or Minimal Stress, 63= Worst Possible Stress) | Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 60 minutes before ET 2) ET day, 10 minutes after ET procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Embryo transfer, Pregnancy rate