Use of VR for Diagnostic Hysteroscopy (VR-HYSTERO)

St. Justine's Hospital

Status: Begins enrollment in 1 month

Conditions: Hysteroscopy; Anxiety; Pain

Treatments: Device: Hypno-Virtual Reality Distraction (HVR); Other: Usual Care Group; Device: Immersive Virtual Reality Distraction (IVR)

Study type: Interventional

Funder types: Other

Identifiers

NCT07173231

VR-HYSTERO

Details and patient eligibility

About

Background: Hysteroscopy (HSC) is a minimally invasive gynecological procedure that is considered to be the gold standard for diagnosing and treating intrauterine pathologies. In recent years, its use in outpatient settings for diagnosis has grown significantly due to its efficiency, low complication rate, and good patient acceptability. However, many patients still report significant pain and anxiety during the procedure. Despite advances in instrumentation and technique, pain remains a key reason for procedural failure, often worsened by preprocedural anxiety. While pharmacological strategies can be used to address this issue, they are not always suitable due to lack of effectiveness or feasibility. As a result, non-pharmacological approaches such as virtual reality (VR) and hypnosis are being increasingly explored. VR has shown potential in reducing pain and anxiety during medical procedures, and its combination with hypnosis may offer enhanced benefits, though current evidence is limited.

Objective: This pilot study aims to assess the effectiveness of immersive virtual reality (IVR) and Hypno-VR (HVR) in managing pain and anxiety during diagnostic HSC and to evaluate the feasibility and acceptability of both IVR and HVR interventions in an outpatient clinical setting.

Methods: This pilot randomized controlled trial (RCT) will follow a three-arm parallel design to compare: 1- standard care, 2- IVR + standard care, and 3- HVR + standard care, during diagnostic HSC. A total of 45 participants (15/arm) will be recruited from the CHU Sainte-Justine's gynecology clinic and randomly assigned to one of the three groups. Primary outcomes will concern feasibility and acceptability including satisfaction of both patients and healthcare professionals. Secondary outcomes will assess self-reported pain and anxiety, physiological responses, procedure duration, procedure failure, and conversion rate from the "no-touch" vaginoscopy technique to traditional tools like the speculum and tenaculum. Demographic characteristics will also be explored as potential moderators of intervention effectiveness.

Results/Conclusion: This pilot study will provide preliminary data on the effects of IVR and HVR on procedural pain and anxiety during diagnostic HSC. It will also assess the feasibility and the acceptability of integrating these interventions into an outpatient setting. The findings will provide essential data in preparation for a larger clinical trial

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum 18 years old
• Speak and read French or English
• Scheduled to undergo a diagnostic hysteroscopy

Exclusion criteria

• Having a diagnosis of epilepsy
• Recent ophthalmologic surgery (< 1month) or any ophtalmologic problems that could interfere with the patient's ability to use the VR technology

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Immersive Virtual Reality Distraction (IVR)

Experimental group

Description:

Use of IVR during diagnostic hysteroscopy

Treatment:

Device: Immersive Virtual Reality Distraction (IVR)

Hypno-Virtual Reality distraction (HVR)

Experimental group

Description:

Use of HVR during diagnostic hysteroscopy

Treatment:

Device: Hypno-Virtual Reality Distraction (HVR)

Usual Care Treatment

Active Comparator group

Description:

Standard protocol offered at CHU Ste-Justine's Hospital before a diagnostic hysteroscopy procedure

Treatment:

Other: Usual Care Group