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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oocyte puncture with local anaesthesia alone | Active Comparator |
| |
| Oocyte puncture with local anaesthesia and additional virtual reality hypnosis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local anaesthetic injection | Drug | 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique mutualiste La Sagesse | Rennes | Brittany Region | 35043 | France |
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Single-centre, comparative, randomised, parallel group study
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The person collecting the endpoints will be blinded to the treatment group
| hypnosis with Virtual reality mask | Device | 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 |
|
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 |
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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