NCT05244538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

February 8, 2022

Last Update Submit

April 22, 2022

Conditions

Virtual Reality TherapyFertilization in VitroPropofolRemifentanilConscious Sedation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient's comfort

    4 hours, during surgery

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

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

Sedation group

ACTIVE COMPARATOR

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

Interventions

Virtual reality distractionDEVICE

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.

Virtual Reality Distraction
Propofol-remifentanil sedationDRUG

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.

Sedation group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patient undergoing in vitro fertilization
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult female patients undergoing oocytes retrieval for in vitro fertilization

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Study Officials

  • Turgay Tuna, MD, PhD

    Erasme University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

February 1, 2022

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

BE(1)