Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05438238 |
| Other study ID # |
VR-OPU |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
June 2022 |
| Source |
Universitair Ziekenhuis Brussel |
| Contact |
Valerie Schutyser, MD |
| Phone |
+32 2 477 2676 |
| Email |
dr.valerie.schutyser[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a comparison between the current standard practice of performing a transvaginal
oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed
technology of virtual reality that is added to the above mentioned standard practice of TVOR
+ PCB. The aim of the study is to find out whether this newer technology has an advantage for
the patient, in terms of anxiety and pain reduction or satisfaction.
Description:
People who wish to become pregnant sometimes have to resort to in vitro fertilisation (IVF)
treatment. IVF treatment consists of the injection of hormones on one hand, and the creation
and transfer of embryos on the other, with a view to pregnancy. The first part, the hormonal
ovarian stimulation, leads to an egg retrieval through the maturation trigger 36h before. On
the one hand, people may be very anxious about the unknown procedure, as they do not know
what to expect. Due to the fertility problems and fertility treatments with its
disappointments, there is also a psychological burden to be taken into consideration. On the
other hand, people may experience this procedure as painful, although this varies greatly.
Scientific studies show that 90% of women are comfortable during transvaginal oocyte
retrieval under local anaesthetic and do not want additional painkillers.
Virtual reality has emerged in recent years as an alternative non-pharmacological treatment
that has proven to be effective in treating burns, postpartum episiotomy suturing or in
paediatric care.
The aim of this study is to investigate the alternative treatment (Virtual Reality glasses)
for its effectiveness in treating anxiety and pain while undergoing transvaginal oocyte
retrieval. The Virtual reality headmounted glasses by Oncomfort, CE certified,is a set of
headphones with a smartphone screen that offers image and sound as a treatment, during the
transvaginal oocyte retrieval, i.e. about 20-30 minutes.
Questionnaires will be filled out by the patients and the physician to evaluate expectations,
fear and pain.
Prior to the TVOR, the patient will fill out the pre-operative questionnaire, which will
interview their baseline fear, anxiety and expectations. Each patient is instructed on the
use of the standard 100mm linear visual analog scale (VAS) with 0 as no pain and 10.0 as the
worst pain imaginable.
In their room, after the TVOR, the patient will receive a second questionnaire (within 4h
after oocyte retrieval, before leaving the hospital) about how the subject has experienced
the exam, in general, at the worst moment, how attractive and immersive the VR was, and
whether she would want to use the VR again.
Five days after the egg retrieval, the patient receives a third and last questionnaire on the
experiences of the remaining day of the egg retrieval as well as the following days.
