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

NCT ID: NCT05567315

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2023-05-26

Brief Summary

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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

Detailed Description

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Conditions

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Oocyte Retrieval

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-centre, comparative, randomised, parallel group study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The person collecting the endpoints will be blinded to the treatment group

Study Groups

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Oocyte puncture with local anaesthesia alone

Group Type ACTIVE_COMPARATOR

local anaesthetic injection

Intervention Type 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)

Oocyte puncture with local anaesthesia and additional virtual reality hypnosis

Group Type EXPERIMENTAL

local anaesthetic injection

Intervention Type 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)

hypnosis with Virtual reality mask

Intervention Type 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

Interventions

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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)

Intervention Type DRUG

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Mutualiste la Sagesse

OTHER

Sponsor Role lead

Responsible Party

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Vincent Denoual

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique mutualiste La Sagesse

Rennes, Brittany Region, France

Site Status

Countries

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France

Other Identifiers

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2021-A02136-35

Identifier Type: -

Identifier Source: org_study_id