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Completed

NCT Number: NCT05244538

Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval

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.

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Key information

Conditions

Virtual Reality Therapy Conscious Sedation Fertilization in Vitro Propofol Remifentanil

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Virtual reality distraction

Device

Patients will be exposed to a virtual reality representing a forest walk. A reduction of at least 50 percent in the remifentanil and propofol doses required for oocyte retrieval is expected.

Propofol-remifentanil sedation

Drug

Target controlled infusion (TCI) of remifentanil will be started at an effect concentration (Ce) of 1.5 ng/mL and TCI propofol at Ce 1.5 ug/mL.

The concentration of remifentanil will be adjusted in 0.5 ng/ml increments based on hand sign from the patient with a maximum effect concentration of remifentanil at 2.5 ng/ml.

Primary outcomes

  1. Dose reduction in propofol and remifentanil requirements

    Time frame: 2 hours

    Total dose of propofol (mg) and remifentanil (mcg) will be recorded in each group. A reduction of at least 50 percent of propofol and remifentanil doses will be expected in order to conclude on a superiority of the virtual reality distraction.

Secondary outcomes

  1. Patient's comfort

    Time frame: 4 hours, during surgery

    Patient comfort will be measured using a five-point Gloucester Comfort scale ranging from 1 (comfortable) to 5 (severe discomfort)

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Interest of Virtual Reality Distraction in the Management of Patients Benefiting From Oocyte Retrieval

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Apr 25, 2022

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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