CompletedNot Applicable

Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia

France90 participantsStarted 2022-09-26

Plain-language summary

Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. Several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. The puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. None of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. General anesthesia is mostly chosen at Rennes, although it exposes to more risks and represents a higher socio-economic cost. Improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. What if virtual reality could be a way to improve the comfort of these patients? Indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. In our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. The expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. The final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of Medically Assisted Reproduction of Rennes, but also in other cities. In the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use. Observational, prospective, randomized, open-label, monocentric study.

Who can participate

Age range

18 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: * Female adult (at least 18 years old) * For whom an oocyte retrieval is planned * Who has had an anesthesia consultation * Who has chosen local anesthesia * Who has signed an informed and written consent * Affiliated to a social security system. Exclusion Criteria: * Pre-existing dizzying sensations * Severe facial wounds * History of epilepsy * Adults under legal protection, curatorship or guardianship, adults deprived of liberty

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.

1This trial tested virtual reality headsets to help manage pain during egg retrieval under local anesthesia — since the trial is now completed, has the data been published, and what did it show about whether VR actually reduced pain compared to not using it?
2Since this study used only local anesthesia rather than sedation during egg retrieval, is local anesthesia an option at our clinic, and do you think it would be appropriate for my situation given my pain tolerance and anxiety levels?
3If VR was found to be helpful in this trial, is it something your clinic currently offers or plans to offer during egg retrieval procedures?
4The trial also looked at anxiety alongside pain — can we talk about what options exist to manage both pain and anxiety during my retrieval, including non-drug approaches like VR, so I can decide what feels right for me?
5Since this was a completed trial with no assigned phase, meaning it was more of a practical evaluation than a drug safety study, how much weight should I give its findings when deciding how I want my own procedure managed?

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

Pain during oocyte retrieval

Timeframe: 30 minutes

Trial details

NCT IDNCT05528497

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Oocyte Retrieval trials