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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05438238

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility In Vitro Fertilization IVF ART	Device: Oncomfort	N/A

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. We know from scientific studies 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, they will receive a second questionnaire (within 4h after oocyte retrieval, before leaving the hospital) about how they have experienced the exam, in general, at the worst moment, how attractive and immersive the VR was, and whether they 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

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 questionnairesThis 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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: investigational group A 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	Device: Oncomfort Virtual Reality
No Intervention: reference group standard of care TVOR + PCB

Arm

Intervention/Treatment

Experimental: investigational group A

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

Device: Oncomfort

Virtual Reality

No Intervention: reference group

standard of care TVOR + PCB

Outcome Measures

Primary Outcome Measures

Difference in VAS for Pain [1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR]
change in pain experience, assessed using visual analog scale

Secondary Outcome Measures

Difference in VAS anxiety [1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR]
change in anxiety experience, assessed using visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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:

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