Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval

NCT ID: NCT07190729

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2025-09-30

Brief Summary

Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed, with the aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.

Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.

However, to date, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published. Our study will evaluate if using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.

Detailed Description

Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed. These devices aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.

Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.

However, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published to date. This study hypothesises that using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.

Conditions

Medically Assisted Procreation (MAP); Oocyte Retrieval

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control arm

Control group: the participants will receive standard propofol sedation procedure

Group Type: ACTIVE_COMPARATOR

Propofol sedation

Intervention Type: OTHER

The participants will receive standard propofol sedation procedure

Experimental arm

Experimental group: the participants will receive standard propofol sedation procedure and the mask -RV Deepsen™

Group Type: EXPERIMENTAL

Propofol sedation + Audiovisual distraction

Intervention Type: DEVICE

The participants will receive standard propofol sedation procedure and the mask -RV Deepsen™

Interventions

Propofol sedation + Audiovisual distraction

The participants will receive standard propofol sedation procedure and the mask -RV Deepsen™

Intervention Type: DEVICE

Propofol sedation

The participants will receive standard propofol sedation procedure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18 and under 43 years of age.
• Requiring propofol sedation for oocyte puncture.
• Who can be contacted directly by telephone the day after the procedure.
• Have given their consent to participate in accordance with the regulations.
• Benfeting of a social security scheme or entitled persons (excluding AME).

Exclusion Criteria

• Active endometriosis.
• Presence of at least one anatomically high ovary which is difficult to puncture.
• Inability to understand the information provided.
• Under guardianship, curatorship or legal protection.
• Under psychiatric care.
• Admitted to a health or social establishment for purposes other than this research.
• Under constraint or deprived of liberty by judicial or administrative decision.
• Impaired communication or neuropsychological disorders.
• Ongoing corneal or conjunctival pathologies.
• Claustrophobia.
• Nausea in the mountains or at sea.
• Use of an anxiolytic or sleeping pill in the 12 hours prior to randomisation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Diaconesses Croix Saint-Simon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, PARIS, France

Countries

France

Other Identifiers

2022-A00311-42

Identifier Type: -

Identifier Source: org_study_id