Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure
- Conditions
- Oocyte Retrieval
- Interventions
- Drug: local anaesthetic injectionDevice: hypnosis with Virtual reality mask
- Registration Number
- NCT05567315
- Lead Sponsor
- Clinique Mutualiste la Sagesse
- Brief Summary
Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 182
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oocyte puncture with local anaesthesia and additional virtual reality hypnosis local anaesthetic injection - Oocyte puncture with local anaesthesia alone local anaesthetic injection - Oocyte puncture with local anaesthesia and additional virtual reality hypnosis hypnosis with Virtual reality mask -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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
Conversion rate from local anaesthesia to unplanned general anaesthesia Immediately after the intervention Conversion rate in percent
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.
Post intervention analgesic therapy Immediately after the intervention Identify the need for postoperative analgesic treatment in the two groups
Gynecologist's numerical satisfaction scale Immediately after the intervention Measure by a numerical scale out of 10, a higher score mean a better outcome.
Patient's numerical satisfaction scale Immediately after the intervention Measure by a numerical scale out of 10, a higher score mean a better outcome.
Trial Locations
- Locations (1)
Clinique mutualiste La Sagesse
🇫🇷Rennes, Bretagne, France