Rennes University Hospital
Rennes, Brittany Region, 35033, France
NCT Number: NCT05528497
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Rennes, Brittany Region, 35033, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of a virtual reality helmet during ovocyte retrieval
Time frame: 30 minutes
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
Time frame: 30 minutes
The assessment criteria used a numerical scale ranging from 0 to 10 (0 = no anxiety, 10 = extremely anxious).
Time frame: 30 minutes
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
Time frame: 30 minutes
The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)
Time frame: 30 minutes
The assessment criteria used is the Likert scale ranging from 1 (Very dissatisfied) to 5 (Very satisfied)
Time frame: 30 minutes
This criteria will be filled in by the gynecologistby the gynecologist who performed the retrieval:
Rennes University Hospital
Other
Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia (OVOREV)
Acronym: OVOREV
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