Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure

Study Overview
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Brief Summary
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Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture

Official Title
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Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure: a Randomised Controlled Study

Conditions
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Oocyte Retrieval

Intervention / Treatment
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* Drug: local anaesthetic injection
* Device: hypnosis with Virtual reality mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient having an oocyte puncture as part of a medically assisted procreation procedure Surgical procedure planned in the operating theatre under local anaesthesia at the Clinique Mutualiste La Sagesse Patient capable of receiving and understanding information about the study and giving written informed consent. Affiliated to a social security system Exclusion Criteria: Patient's refusal to participate in a study Patient having an oocyte retrieval as part of an oocyte donation Unbalanced epilepsy. Hearing and/or visual impairments that contraindicate the use of the virtual reality headset. Patient with a poor understanding of the French language. Medical indication to carry out the oocyte puncture under general anaesthesia Drug allergy or hypersensitivity to PARACETAMOL - IBUPROFEN or NEFOPAM prescribed during the pre-medication. Patient under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre, comparative, randomised, parallel group study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oocyte puncture with local anaesthesia alone<br> | Drug: local anaesthetic injection<br>* Infiltration of 40 to 80 ml of a non-adrenalized 0.5% lidocaine solution into the vaginal wall at the level of the vaginal pouches, under ultrasound guidance. (within the limit of the toxic doses, i.e. 5mg/kg)<br>|
| Experimental: Oocyte puncture with local anaesthesia and additional virtual reality hypnosis<br> | Drug: local anaesthetic injection<br>* Infiltration of 40 to 80 ml of a non-adrenalized 0.5% lidocaine solution into the vaginal wall at the level of the vaginal pouches, under ultrasound guidance. (within the limit of the toxic doses, i.e. 5mg/kg)<br>Device: hypnosis with Virtual reality mask<br>* A 20-minute virtual reality hypnosis session is performed from the time the patient is placed on the surgical table until the end of the oocyte poncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Nociception Index (ANI) measurement | The level of pain perceived by the patient during the performance of a painful care procedure will be measured by the ANI index which reflects heart rate variability | during oocyte puncture procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety with beck anxiety inventory | Measurement of anxiety by the Beck Anxiety Inventory, on admission to hospital and on return to the ward, 1 hour after the oocyte puncture | 1 hour before intervention and immediately after the intervention | 
| Simulator Sickness Questionnaire (SSQ) | Assessment of tolerance of virtual reality with SSQ ; SSQ is a scale of cyber sickness from 0 to 48, a higher score mean a worse outcome. | Immediately after the intervention | 
| Analog visual scale (AVS) | Pain evaluation with Analog visual scale by the patient himself from 0 to 10, a higher score mean a worse outcome. | Immediately after the intervention | 
| Post intervention analgesic therapy | Identify the need for postoperative analgesic treatment in the two groups | Immediately after the intervention | 
| Total duration of the procedure of oocyte ponction (min) | Total duration of the procedure (min), from the beginning of local anesthesia to the end of the oocyte retrieval | From the first ponction of local anesthesia to the end of the retrieval of the last oocyte | 
| Conversion rate from local anaesthesia to unplanned general anaesthesia | Conversion rate in percent | Immediately after the intervention | 
| Gynecologist's numerical satisfaction scale | Measure by a numerical scale out of 10, a higher score mean a better outcome. | Immediately after the intervention | 
| Patient's numerical satisfaction scale | Measure by a numerical scale out of 10, a higher score mean a better outcome. | Immediately after the intervention |