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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Device: Oncomfort, commercially available Virtual Reality headset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: investigational group<br>Virtual Reality | Device: Oncomfort, commercially available Virtual Reality headset<br>* Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC<br>|
| No Intervention: reference group<br>standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, hysteroscopy, infertility