Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.

Official Title
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Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate

Conditions
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Anxiety, in Vitro Fertilization, Virtual Reality

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc. Simple IVF / IVF Intracytoplasmic sperm injection (ICSI) Exclusion Criteria: Patients with long-term psychotherapeutic treatment Patients taking psychotropic drugs patient blind and deaf

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Virtual Reality Neutral<br>neutral VR session before oocytes retrieval | Device: Virtual reality<br>* a device with virtual reality is given to the patients with a film of 18 minutes<br>|
| Active Comparator: Virtual reality Anxiety<br>VR session with the goal of reducing anxiety before oocytes retrieval | Device: Virtual reality<br>* a device with virtual reality is given to the patients with a film of 18 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of the virtual reality on the pregnancy rate (Ultrasound) | measured by ultrasound | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of the virtual reality on anxiety (numeric scale) | measured with numeric scale (0-10) before and after the VR | immediate | 
| impact of the virtual reality on satisfaction | measured by a numeric scale 0-10 | immediate | 
| impact of the virtual reality on pregnancy test | measured by blood beta HCG level | 6 weeks | 
| state-trait Anxiety Inventory | measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital | immediate |