NCT07190729

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Propofol sedation + Audiovisual distraction	The participants will receive standard propofol sedation procedure and the mask -RV Deepsen™
OTHER	Propofol sedation	The participants will receive standard propofol sedation procedure

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-09-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: France