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

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

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

Study Overview

• Status: Completed
• Conditions: Oocyte Retrieval
• Intervention / Treatment: Drug: local anaesthetic injection; Device: hypnosis with Virtual reality mask

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35043
      • Clinique mutualiste La Sagesse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oocyte puncture with local anaesthesia alone	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)
Experimental: Oocyte puncture with local anaesthesia and additional virtual reality hypnosis	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinique Mutualiste la Sagesse

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 2021-A02136-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No