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Completed

NCT Number: NCT05528497

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR+

Other

Use of a virtual reality helmet during ovocyte retrieval

Primary outcomes

  1. 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

  1. Anxiety during oocyte retrieval

    Time frame: 30 minutes

    The assessment criteria used a numerical scale ranging from 0 to 10 (0 = no anxiety, 10 = extremely anxious).

  2. Immediate postoperative pain

    Time frame: 30 minutes

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

  3. The pain felt by the patient during the oocyte retrieval, according to the gynecologist who did the retrieval

    Time frame: 30 minutes

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

  4. immediate postoperative satisfaction

    Time frame: 30 minutes

    The assessment criteria used is the Likert scale ranging from 1 (Very dissatisfied) to 5 (Very satisfied)

  5. Use of a complementary sedation or a general anesthesia

    Time frame: 30 minutes

    This criteria will be filled in by the gynecologistby the gynecologist who performed the retrieval:

    • Only local anesthesia
    • Use of an additional sedation
    • Switch to general anesthesia

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: OVOREV

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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