Virtual Reality for Acute Pain and Anxiety During Egg Retrieval for in Vitro Fertility Treatment

U

Universitair Ziekenhuis Brussel

Status

Enrolling

Conditions

In Vitro Fertilization
IVF
Infertility
ART

Treatments

Device: Oncomfort

Study type

Interventional

Funder types

Other

Identifiers

NCT05438238
VR-OPU

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • female
  • ≥18 and ≤ 40 years of age
  • undergoing fertility treatments
  • undergoing egg retrieval as part of in vitro fertilization treatment
  • only first ≤ 3 IVF cycles.
  • Bilateral ovarian follicular response (>3 and <30 follicles)

Exclusion criteria

  • Hearing impairments and blindness
  • Motion sickness
  • Any known anatomical characteristics that may make performing the office procedure impossible.
  • Patients undergoing a general anesthesia or conscious sedation
  • lack of informed consent
  • Chronic alcohol/drug abusers
  • Transabdominal approach for retrieval
  • Patients undergoing oocyte retrieval for fertility preservation before cancer or genotoxic treatment - oncofertility preservation
  • allergy to medications used

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

investigational group A
Experimental group
Description:
during TVOR +PCB addition of Oncomfort, commercially available Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform IEC62366-1:2015, EN 62304:2006/Amd1:2015, EN 82304-1:2015, EN 82304-1:2016, ISO 13485:2016, EN ISO 14971:2019, EN 60601-1-2:2015
Treatment:
Device: Oncomfort
reference group
No Intervention group
Description:
standard of care TVOR + PCB

Trial contacts and locations

1

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Central trial contact

Valerie Schutyser, MD; Elsie Nulens

Data sourced from clinicaltrials.gov

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