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

NCT07190729 | Completed DMC

• 1 other identifier: 2022-A00311-42
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Medically Assisted Procreation (MAP); Oocyte Retrieval

Keywords

Virtual reality; Propofol sedation

Outcome Measures

Primary Outcomes (2)

• The Cp50 value of propofol in each group.

  The Cp50 is defined as the median of the target concentration at which 50% of participants showed movement during the oocyte puncture procedure. Any difference between the two groups will be determined using Dixon's up and down technique

  Day 0

• The number and proportion of participants not requiring sedation

  Day 0

Secondary Outcomes (9)

• Effect on procedural anxiety

  Day 0

• Tolerating audiovisual distraction

  48 hours

• Pain on injection of propofol

  Day 0

• Complications observed during anaesthesia

  Day 0

• The time required to walk

  Day 0

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Control group: the participants will receive standard propofol sedation procedure

Other: Propofol sedation

Experimental arm

EXPERIMENTAL

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

Device: Propofol sedation + Audiovisual distraction

Interventions

Propofol sedation + Audiovisual distraction DEVICE

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

Experimental arm

Propofol sedation OTHER

The participants will receive standard propofol sedation procedure

Control arm

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, PARIS, 75020, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group: standard propofol sedation procedure Experimental group: standard propofol sedation procedure + mask -RV Deepsen™

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: April 4, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)