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Clinical Trials/NCT05528497
NCT05528497
Recruiting
Not Applicable

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

Rennes University Hospital1 site in 1 country90 target enrollmentSeptember 26, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oocyte Retrieval
Sponsor
Rennes University Hospital
Enrollment
90
Locations
1
Primary Endpoint
Pain during oocyte retrieval
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 26, 2022
End Date
May 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain during oocyte retrieval

Time Frame: 30 minutes

The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)

Secondary Outcomes

  • Anxiety during oocyte retrieval(30 minutes)
  • The pain felt by the patient during the oocyte retrieval, according to the gynecologist who did the retrieval(30 minutes)
  • Use of a complementary sedation or a general anesthesia(30 minutes)
  • Immediate postoperative pain(30 minutes)
  • immediate postoperative satisfaction(30 minutes)

Study Sites (1)

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