Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in In Vitro Fecondation Protocols: Controlled Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Pain during oocyte retrieval, assessed by NRS
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 18 and 43 years
- •First attempt of oocyte retrieval under local anesthesia in the context of a protocol for Medically Assisted Procreation
Exclusion Criteria
- •Former attempt of oocyte retrieval
- •Poor oocyte stock : > 40 years AND low markers (AMH < 0.5-1.1 ng/ml OR AFC < 5-7)
- •Unsteady epilepsia
Arms & Interventions
Virtual Reality Group
in this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia)
Intervention: Hypnotic relaxation induced by virtual reality (device) (Device)
Virtual Reality Group
in this group, patients will use virtual reality during the oocyte retrieval plus the standard anesthesic procedure (local anesthesia)
Intervention: local anesthesia (Drug)
Standard Group
in this group, patients will receive the standard anesthesic procedure during the oocyte retrieval wich is local anesthesia
Intervention: local anesthesia (Drug)
Outcomes
Primary Outcomes
Pain during oocyte retrieval, assessed by NRS
Time Frame: day 0 (During the intervention for oocyte retrieval)
Oral evaluation of pain during the intervention for oocyte retrieval, evaluated by a Numeric Rating Scale (NRS) : from 0 (meaning no pain at all) to 10 (meaning worse pain possible).
Secondary Outcomes
- Painkillers consumption during the 48 hours following the oocyte retrieval.(Day 5)
- Patient satisfaction concerning the use of virtual reality during the oocyte retrieval(hour 1 (In the hour following the oocyte retrival))
- Gynaecologist satisfaction concerning the use of virtual reality during the oocyte retrieval(hour 1 (In the hour following the oocyte retrival))
- Efficacy of the use of virtual reality during oocyte retrieval(hour 1 (In the hour following the oocyte retrival))
- Pain after oocyte retrieval, assessed by NRS(hour 1 (In the hour following the oocyte retrival))