Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval

April 22, 2022 updated by: Erasme University Hospital

Interest of Virtual Reality Distraction in the Management of Patients Benefiting From 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Distraction
In the experimental group, patients will benefit from a 20-minute VR. 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, patients will watch the same VR program again.The TCI remifentanil and propofol will be connected to the infusion but will be stopped and titrated if discomfort.
Device: Virtual reality distraction
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.
Active Comparator: Sedation group

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.

The concentration of propofol will be adjusted by an effect concentration of 0.5 ug/ml with a maximum of 1.5 ug/ml, in this case according to a 5-point scale

  1. fully awake and oriented
  2. drowsy
  3. eyes closed, responds quickly to verbal commands
  4. eyes closed, aroused only by mild physical stimulation
  5. eyes closed, not aroused by mild physical stimulation) A sedation score of 3 will be the target throughout the procedure.
Drug: Propofol-remifentanil sedation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 hours, during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Study Director: Turgay Tuna, MD, PhD, Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

April 11, 2022

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPNOFIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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