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NCT04438759 Clinical Trial

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

Infertility, Female Clinical Trial

— HYSVIR  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04438759
Other study ID # HYSVIR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2020
Est. completion date December 31, 2021

Study information
Verified date June 2022
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date December 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 48 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Oncomfort, 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

Locations
Country Name City State
Belgium UZ Brussel CRG Jette Brussels

Sponsors (1)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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'. 1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure
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