Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypn… (NCT07190729) | Clinical Trial Compass
CompletedNot Applicable
Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval
France52 participantsStarted 2023-04-04
Plain-language 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.
Who can participate
Age range
18 Years – 43 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Cp50 value of propofol in each group.
Timeframe: Day 0
2
The number and proportion of participants not requiring sedation