Recruiting

IVR & HVR

Sponsor:

St. Justine's Hospital

Code:

NCT07173231

Conditions

Hysteroscopy

Anxiety

Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immersive Virtual Reality Distraction (IVR)

Hypno-Virtual Reality Distraction (HVR)

Usual Care Group

Study Details

Brief summary:

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.

Objective: This pilot study aims to assess the feasibility, acceptability and preliminary effects of immersive virtual reality (IVR) and Hypno-VR (HVR) in managing pain and anxiety during diagnostic HSC.

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

Conditions

Hysteroscopy

Anxiety

Pain

Study ID

NCT07173231

Start date

Jul 8, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Immersive Virtual Reality Distraction (IVR)

Use of IVR during diagnostic hysteroscopy

experimental: Hypno-Virtual Reality distraction (HVR)

Use of HVR during diagnostic hysteroscopy

active comparator: Usual Care Treatment

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

Interventions

Immersive Virtual Reality Distraction (IVR)

The first experimental group will receive the INSPIRE® IVR intervention in addition to usual care. This intervention integrates immersive virtual environments with sensor-guided deep breathing techniques to engage the parasympathetic nervous system and promote relaxation. Within a calming forest environment, participants are guided to synchronize their breathing with the movement of a feather, encouraging breath control and relaxation.

Hypno-Virtual Reality Distraction (HVR)

The second experimental group will receive the HVR intervention in addition to usual care. This intervention, developed by HypnoVR, consists of a VR visual scenario combined with hypnotic verbal guidance specifically designed to reduce pain and anxiety during medical procedures.

Usual Care Group

The usual care group will only receive the standard preparation, which includes pre-treatment with Tylenol (1000mg) , Naproxen (500mg) and Ativan (1 mg) administered one hour prior to the procedure.

Primary outcome measure

  • Completion rate of the planned intervention [ Time Frame: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) ]
  • Recruitment rate [ Time Frame: To be reported right before the procedure, at baseline (T0) ]
  • The healthcare professionals' satisfaction level [ Time Frame: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) ]
  • The patient's satisfaction level [ Time Frame: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) ]
  • Patient's acceptability towards the intervention [ Time Frame: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) ]

Central Contacts and Locations

Central contacts

Sylvie Le May PhD

5143454931sylvie.lemay@umontreal.ca

Locations

CHU Sainte-Justine Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Sylvie Le May, RN, PhD, FCAN

1-514-345-4931sylvie.lemay@umontreal.ca

sylvie.lemay@umontreal.ca

Principal Investigator:

Sylvie Le May, RN, PhD, FCAN

More Information

Sponsor

St. Justine's Hospital

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • women's health
  • hysteroscopy
  • anxiety
  • procedural pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.