Clinical trial NCT05244538: Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval
Official title: Interest of Virtual Reality Distraction in the Management of Patients Benefiting From Oocyte Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality Therapy
Fertilization in Vitro
Propofol
Remifentanil
Conscious Sedation
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares hypnosis via virtual reality to sedation with commonly used intravenous anesthetic agents (propofol and remifentanil) during oocyte retrieval.

The main objective of this prospective randomized controlled study will be a reduction of 50 percent of the doses of remifentanil and propofol administered during oocyte retrieval while maintaining satisfaction with the quality of care.

Detailed description: Transvaginal ultrasound-guided oocyte retrieval is a fundamental step in the treatment of in vitro fertilization (IVF).

To date, no anesthetic technique has demonstrated superiority in terms of efficacy, tolerance or analgesia.

Virtual Reality Distraction has been studied for its clinical applications.

Patients will be included during the consultation with either the gynecologist or the anesthetist who will explain the protocol to the patient and give her consent to sign.

After obtaining their informed consent, the patient will be randomized into two groups based on a computer-generated randomization list (QuickCalcs program; GraphPad Software Inc) either into the experimental or in the control group.

In the experimental group, patients will benefit from a 20-minute virtual reality. Patients will watch a forest walk in virtual reality while listening to narrations designed to induce relaxation and meditation. If the oocyte retrieval was not completed within 20 minutes, the patient will watch the virtual reality program again. The target-controlled infusion of remifentanil and propofol will be connected to the patient, and only titrated to patient's comfort.

In the control group, patients will immediately benefit from an infusion of remifentanil and propofol titrated in a well-protocolized manner according to the patient's comfort.

Eligibility criteria: Inclusion Criteria:

* Adult female patients undergoing oocytes retrieval for in vitro fertilization

Exclusion Criteria:

* Presence of any psychiatric disorders
* Presence of a visual acuity disorder or hearing abnormality.
* Dementia
* Limited knowledge of French
* Diagnosis of balance disorders or epilepsy
* Claustrophobia
* Stage 4 endometriosis.

Primary outcomes:
measure: Dose reduction in propofol and remifentanil requirements
timeFrame: 2 hours
Secondary outcomes:
measure: Patient's comfort
timeFrame: 4 hours, during surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme University Hospital
name: Turgay Tuna, MD, PhD
role: STUDY_DIRECTOR
References: