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

NCT04438759 | Completed

• 1 other identifier: HYSVIR
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

virtual reality; hysteroscopy; infertility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

investigational group

EXPERIMENTAL

Virtual Reality

Device: Oncomfort, commercially available Virtual Reality headset

reference group

NO INTERVENTION

standard of care

Interventions

Oncomfort, commercially available Virtual Reality headset DEVICE

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

investigational group

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: hysteroscopy requires presence of uterus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, …

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel CRG

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• valerie schutyser

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 28, 2020
• First Posted: June 19, 2020
• Study Start: September 10, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)