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

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Device: Oncomfort, commercially available Virtual Reality headset

• Registration Number: NCT04438759
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-09-10
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
investigational group	Oncomfort, commercially available Virtual Reality headset	Virtual Reality

Primary Outcome Measures

Name	Time	Method
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'.

Trial Locations

Locations (1)

UZ Brussel CRG; 🇧🇪 Jette, Brussels, Belgium