NCT05528497: OVOREV

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

Status unknown NA Last updated 12 April 2023

What this trial tests

NA trial testing VR+ in Oocyte Retrieval in 90 participants. Status unknown.

Timeline

26 September 2022

Primary endpoint
1 February 2024

1 May 2024

Quick facts

Lead sponsor	Rennes University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	90
Start date	26 September 2022
Primary completion	1 February 2024
Estimated completion	1 May 2024
Sites	1 location across France

Drugs / interventions tested

• VR+

Conditions studied

• Oocyte Retrieval — all drugs for Oocyte Retrieval →
• Local Anaesthesia — all drugs for Local Anaesthesia →
• Virtual Reality — all drugs for Virtual Reality →

Sponsor

Rennes University Hospital

Who can join

18 and older, female only, with Oocyte Retrieval or Local Anaesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.