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

Primary Purpose

Infertility, Female

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Oncomfort, commercially available Virtual Reality headset

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring virtual reality, hysteroscopy, infertility

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

UZ Brussel CRG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

investigational group

reference group

Arm Description

Virtual Reality

standard of care

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Full Information

NCT ID

NCT04438759

First Posted

February 28, 2020

Last Updated

July 8, 2022

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04438759

Brief Title

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

Acronym

HYSVIR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female

Keywords

virtual reality, hysteroscopy, infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

investigational group

Arm Type

Experimental

Arm Description

Virtual Reality

Arm Title

reference group

Arm Type

No Intervention

Arm Description

standard of care

Intervention Type

Device

Intervention Name(s)

Oncomfort, commercially available Virtual Reality headset

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in pain experience as assessed using visual analog scale

Description

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

hysteroscopy requires presence of uterus

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

valerie schutyser

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Brussel CRG

City

Jette

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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