Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval

Sponsor

Erasme University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05244538

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality Therapy Fertilization in Vitro Propofol Remifentanil Conscious Sedation	Device: Virtual reality distraction Drug: Propofol-remifentanil sedation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Apr 11, 2022

Actual Study Completion Date :

Apr 11, 2022

Arms and Interventions

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 fully awake and oriented drowsy eyes closed, responds quickly to verbal commands eyes closed, aroused only by mild physical stimulation 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.

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 fully awake and oriented drowsy eyes closed, responds quickly to verbal commands eyes closed, aroused only by mild physical stimulation eyes closed, not aroused by mild physical stimulation) A sedation score of 3 will be the target throughout the procedure.

Drug: Propofol-remifentanil sedation

Outcome Measures

Primary Outcome Measures

Dose reduction in propofol and remifentanil requirements [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 Outcome Measures

Patient's comfort [4 hours, during surgery]
Patient comfort will be measured using a five-point Gloucester Comfort scale ranging from 1 (comfortable) to 5 (severe discomfort)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasme University Hospital	Brussels		Belgium	1070

Sponsors and Collaborators

Erasme University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT05244538

Other Study ID Numbers:

HYPNOFIV

First Posted:

Feb 17, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Remifentanil

Propofol

Study Results

No Results Posted as of Apr 25, 2022