NCT04935658

Oocyte Retrieval and Virtual Reality (REVPO)

Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in in Vitro Fecondation Protocols: Controlled Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to ass wether or not the use of virtual reality during oocyte retrieval provides a better pain relief for patients, compared to a standard analgesic procedure.

Detailed description

Patients will be included during the consultation with the gynaecologist, whom will explain the protocol to the patient and give her the consent to sign. The patient will be then randomized by a computer (using the software REDCAP) into either the experimental group or the standard group. In the experimental group, a virtual reality device will be installed on the patient as soon as she arrives in the operating room, and the intervention will start after 3-5 minutes. In both group, the patient will benefit of a local anesthesia in the vagina, and if they want it of an oral analgesic before the intervention. Just at the end of the intervention, the pain will be evaluated orally by the nurse, using a Numeric Rating Scale. This consist of the Primary Outcome. After the intervention, the gynaecologist will fill a form assessing his satisfaction concerning the use of virtual reality during the intervention (efficacy, security...) One hour after the intervention, the patient will fill a form about her self-estimation of the post-procedural pain and her satisfaction concerning the use of virtual reality. The number of oocytes collected and the number of oocytes expected on the ultrasound monitoring will be gathered and a ratio will be calculated, in order to estimate the efficacy of the retrieval. Five days after the intervention, the patient will have to fill a form evaluating her consumption of painkillers during the 48hours following the intervention.

Conditions

• Oocyte Retrieval
• Pain
• Fertilization in Vitro

Interventions

Type	Name	Description
DEVICE	Hypnotic relaxation induced by virtual reality (device)	A virtual reality device will be install on the patient 3-5 minutes before the beginning of the oocyte retrieval. The device will be wearing by the patient during the entire intervention and 2 minutes after the end of the ponction.
DRUG	local anesthesia	standard anesthesic procedure

Timeline

• Start date: 2021-06-09
• Primary completion: 2024-03-01
• Completion: 2024-07-01
• First posted: 2021-06-23
• Last updated: 2024-09-19

Locations

1 site across 1 country: France