Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval

Conscious Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244538
• Other study ID #: HYPNOFIV
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2022
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conscious Sedation
• Fertilization in Vitro
• Propofol
• Remifentanil
• Virtual Reality Therapy

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose reduction in propofol and remifentanil requirements	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	Patient's comfort	Patient comfort will be measured using a five-point Gloucester Comfort scale ranging from 1 (comfortable) to 5 (severe discomfort)	4 hours, during surgery