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

Oocyte Retrieval Clinical Trial

— HypnoPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567315
• Other study ID #: 2021-A02136-35
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: May 26, 2023

Study information

• Verified date: December 2023
• Source: Clinique Mutualiste la Sagesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Oocyte Retrieval

Intervention

Drug:
• local anaesthetic injection
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)

Device:
• hypnosis 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

Locations

Country	Name	City	State
France	Clinique mutualiste La Sagesse	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Mutualiste la Sagesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Post intervention analgesic therapy	Identify the need for postoperative analgesic treatment in the two groups	Immediately after the intervention
Secondary	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
Secondary	Conversion rate from local anaesthesia to unplanned general anaesthesia	Conversion rate in percent	Immediately after the intervention
Secondary	Gynecologist's numerical satisfaction scale	Measure by a numerical scale out of 10, a higher score mean a better outcome.	Immediately after the intervention
Secondary	Patient's numerical satisfaction scale	Measure by a numerical scale out of 10, a higher score mean a better outcome.	Immediately after the intervention