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

Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Egg Retrieval for in Vitro Fertility Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05438238
Enrollment
300
Registered
2022-06-29
Start date
2023-02-01
Completion date
2024-12-31
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ART, Infertility, In Vitro Fertilization, IVF

Keywords

virtual reality, infertility, transvaginal oocyte retrieval, IVF, in vitro fertilization

Brief 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.

Detailed 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.

Interventions

DEVICEOncomfort

Virtual Reality

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This study is a comparison between the current standard practice of performing an egg retrieval with paracervical block (PCB) and 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, by aid of questionnaires

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

1. Hearing impairments and blindness 2. Motion sickness 3. Any known anatomical characteristics that may make performing the office procedure impossible. 4. Patients undergoing a general anesthesia or conscious sedation 5. lack of informed consent 6. Chronic alcohol/drug abusers 7. Transabdominal approach for retrieval 8. Patients undergoing oocyte retrieval for fertility preservation before cancer or genotoxic treatment - oncofertility preservation 9. allergy to medications used

Design outcomes

Primary

MeasureTime frameDescription
Difference in visual analog scale score for Pain1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVORchange in pain experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no pain and 10.0 as the worst pain imaginable.

Secondary

MeasureTime frameDescription
Difference in visual analog scale score for anxiety1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVORchange in anxiety experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no fear and 10.0 as the worst fear imaginable/ dying of fear

Countries

Belgium

Contacts

Primary ContactValerie Schutyser, MD
dr.valerie.schutyser@gmail.com+32 2 477 2676
Backup ContactElsie Nulens
elsie.nulens@uzbrussel.be+32 2 477 2676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026