- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438759
Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility (HYSVIR)
July 8, 2022 updated by: Universitair Ziekenhuis Brussel
Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Outpatient Hysteroscopy and Endometrial Biopsy in Subfertility Patients
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Brussels
-
Jette, Brussels, Belgium, 1090
- UZ Brussel CRG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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:
- Hearing impairments and blindness
- Motion sickness
- Any known anatomical characteristics that may make performing the office procedure impossible.
- The unwillingness of the patient to undergo an office hysteroscopy
- Denial or withdrawal of informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: investigational group
Virtual Reality
|
Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en,
CE approval conform 93/42/EEC and 2007/47/EEC
|
No Intervention: reference group
standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain experience as assessed using visual analog scale
Time Frame: 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'.
|
1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: valerie schutyser, Universitair Ziekenhuis Brussel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2020
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
February 28, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (Actual)
June 19, 2020
Study Record Updates
Last Update Posted (Actual)
July 11, 2022
Last Update Submitted That Met QC Criteria
July 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYSVIR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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