Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility

Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Outpatient Hysteroscopy and Endometrial Biopsy in Subfertility Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04438759

Acronym

HYSVIR

Enrollment

216

Registered

2020-06-19

Start date

2020-09-10

Completion date

2021-12-31

Last updated

2022-07-11

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

Conditions

Infertility, Female

Keywords

virtual reality, hysteroscopy, infertility

Brief summary

This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.

Interventions

DEVICEOncomfort, commercially available Virtual Reality headset

Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

Healthy volunteers

Yes

Inclusion criteria

* undergoing fertility treatments * for which outpatient hysteroscopy has been prescribed * for different possible indications: suspicion of intracavitary pathology, recurrent implantation failure, recurrent early pregnancy loss, …

Exclusion criteria

1. Hearing impairments and blindness 2. Motion sickness 3. Any known anatomical characteristics that may make performing the office procedure impossible. 4. The unwillingness of the patient to undergo an office hysteroscopy 5. Denial or withdrawal of informed consent

Design outcomes

Primary

Measure	Time frame	Description
Change in pain experience as assessed using visual analog scale	1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure	quantified through visual analog scale: from 0.0 to 10.0cm, ranging from 0.0 meaning 'No pain' and 10.0 representing 'worst imaginable pain'.

Countries

Belgium

Outcome results

None listed

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