Oocyte Retrieval
Conditions
Brief summary
Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture
Interventions
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)
DEVICEhypnosis with Virtual reality mask
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
Sponsors
Clinique Mutualiste la Sagesse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The person collecting the endpoints will be blinded to the treatment group
Intervention model description
Single-centre, comparative, randomised, parallel group study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia Nociception Index (ANI) measurement | during oocyte puncture procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety with beck anxiety inventory | 1 hour before intervention and immediately after the intervention | Measurement of anxiety by the Beck Anxiety Inventory, on admission to hospital and on return to the ward, 1 hour after the oocyte puncture |
| Simulator Sickness Questionnaire (SSQ) | Immediately after the intervention | 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. |
| Analog visual scale (AVS) | Immediately after the intervention | Pain evaluation with Analog visual scale by the patient himself from 0 to 10, a higher score mean a worse outcome. |
| Gynecologist's numerical satisfaction scale | Immediately after the intervention | Measure by a numerical scale out of 10, a higher score mean a better outcome. |
| Total duration of the procedure of oocyte ponction (min) | From the first ponction of local anesthesia to the end of the retrieval of the last oocyte | Total duration of the procedure (min), from the beginning of local anesthesia to the end of the oocyte retrieval |
| Conversion rate from local anaesthesia to unplanned general anaesthesia | Immediately after the intervention | Conversion rate in percent |
| Patient's numerical satisfaction scale | Immediately after the intervention | Measure by a numerical scale out of 10, a higher score mean a better outcome. |
| Post intervention analgesic therapy | Immediately after the intervention | Identify the need for postoperative analgesic treatment in the two groups |
Countries
France
Outcome results
None listed