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

Universitair Ziekenhuis Brussel216 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

216

Conditions

Infertility, Female

Interventions

Oncomfort, commercially available Virtual Reality headsetDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UZ Brussel CRG

Jette, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Change in pain experience as assessed using visual analog scale

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'.

Time frame: 1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure

Data from ClinicalTrials.gov

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