Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval

Study Overview
=================
Brief Summary
-----------------
This study compares hypnosis via virtual reality to sedation with commonly used intravenous anesthetic agents (propofol and remifentanil) during oocyte retrieval. The main objective of this prospective randomized controlled study will be a reduction of 50 percent of the doses of remifentanil and propofol administered during oocyte retrieval while maintaining satisfaction with the quality of care.

Detailed Description
-----------------
Transvaginal ultrasound-guided oocyte retrieval is a fundamental step in the treatment of in vitro fertilization (IVF). To date, no anesthetic technique has demonstrated superiority in terms of efficacy, tolerance or analgesia. Virtual Reality Distraction has been studied for its clinical applications. Patients will be included during the consultation with either the gynecologist or the anesthetist who will explain the protocol to the patient and give her consent to sign. After obtaining their informed consent, the patient will be randomized into two groups based on a computer-generated randomization list (QuickCalcs program; GraphPad Software Inc) either into the experimental or in the control group. In the experimental group, patients will benefit from a 20-minute virtual reality. Patients will watch a forest walk in virtual reality while listening to narrations designed to induce relaxation and meditation. If the oocyte retrieval was not completed within 20 minutes, the patient will watch the virtual reality program again. The target-controlled infusion of remifentanil and propofol will be connected to the patient, and only titrated to patient's comfort. In the control group, patients will immediately benefit from an infusion of remifentanil and propofol titrated in a well-protocolized manner according to the patient's comfort.

Official Title
-----------------
Interest of Virtual Reality Distraction in the Management of Patients Benefiting From Oocyte Retrieval

Conditions
-----------------
Virtual Reality Therapy, Fertilization in Vitro, Propofol, Remifentanil, Conscious Sedation

Intervention / Treatment
-----------------
* Device: Virtual reality distraction
* Drug: Propofol-remifentanil sedation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult female patients undergoing oocytes retrieval for in vitro fertilization Exclusion Criteria: Presence of any psychiatric disorders Presence of a visual acuity disorder or hearing abnormality. Dementia Limited knowledge of French Diagnosis of balance disorders or epilepsy Claustrophobia Stage 4 endometriosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Distraction<br>In the experimental group, patients will benefit from a 20-minute VR. Patients will watch a forest walk in virtual reality while listening to narrations designed to induce relaxation and meditation. If the oocyte retrieval was not completed within 20 minutes, patients will watch the same VR program again.The TCI remifentanil and propofol will be connected to the infusion but will be stopped and titrated if discomfort. | Device: Virtual reality distraction<br>* Patients will be exposed to a virtual reality representing a forest walk. A reduction of at least 50 percent in the remifentanil and propofol doses required for oocyte retrieval is expected.<br>|
| Active Comparator: Sedation group<br>Target controlled infusion (TCI) of remifentanil will be started at an effect concentration (Ce) of 1.5 ng/mL and TCI propofol at Ce 1.5 ug/mL. The concentration of remifentanil will be adjusted in 0.5 ng/ml increments based on hand sign from the patient with a maximum effect concentration of remifentanil at 2.5 ng/ml. The concentration of propofol will be adjusted by an effect concentration of 0.5 ug/ml with a maximum of 1.5 ug/ml, in this case according to a 5-point scale fully awake and oriented drowsy eyes closed, responds quickly to verbal commands eyes closed, aroused only by mild physical stimulation eyes closed, not aroused by mild physical stimulation) A sedation score of 3 will be the target throughout the procedure. | Drug: Propofol-remifentanil sedation<br>* Target controlled infusion (TCI) of remifentanil will be started at an effect concentration (Ce) of 1.5 ng/mL and TCI propofol at Ce 1.5 ug/mL. The concentration of remifentanil will be adjusted in 0.5 ng/ml increments based on hand sign from the patient with a maximum effect concentration of remifentanil at 2.5 ng/ml.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose reduction in propofol and remifentanil requirements | Total dose of propofol (mg) and remifentanil (mcg) will be recorded in each group. A reduction of at least 50 percent of propofol and remifentanil doses will be expected in order to conclude on a superiority of the virtual reality distraction. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's comfort | Patient comfort will be measured using a five-point Gloucester Comfort scale ranging from 1 (comfortable) to 5 (severe discomfort) | 4 hours, during surgery |