Use of VR for Diagnostic Hysteroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSt. Justine's Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Minimum 18 years old
Speak and read French or English
Scheduled to undergo a diagnostic hysteroscopy
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Immersive Virtual Reality Distraction (IVR)
DeviceThe 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)
DeviceThe 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
Other interventionThe 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Immersive Virtual Reality Distraction (IVR)Experimental treatment 1 intervention
Group B: Hypno-Virtual Reality distraction (HVR)Experimental treatment 1 intervention
Group C: Usual Care TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Completion rate of the planned intervention
Completion rate of the planned intervention will be assessed as the proportion of participants who complete their allocated intervention out of the total number of participants randomized.
Time frame
To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)2
Recruitment rate
Recruitment rate will be assessed as the proportion of patients who consent to participate out of the total number of HSC procedures performed.
Time frame
To be reported right before the procedure, at baseline (T0)3
The healthcare professionals' satisfaction level
The healthcare professionals' satisfaction level will be assessed using a customized questionnaire comprising 7-10 items, depending on the intervention used. Each item will be rated on a four-point Likert scale, ranging from "Strongly agree" to "Strongly disagree," evaluating their satisfaction with the intervention and its perceived impact on the procedure (T2).
Time frame
To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)4
The patient's satisfaction level
The patient's satisfaction level towards the intervention will be assessed using a Verbal Numerical Rating Scale (VNRS), ranging from 0 to 10, where 0 indicates "very dissatisfied" and 10 indicates "very satisfied." Patients will be asked the following question: "Considering anxiety relief, pain relief, side effects, and emotional recovery, how satisfied were you with the treatments you received during the procedure?" (T2).
Time frame
To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)Secondary outcomes
1
Pain intensity
Pain intensity will be measured using the Verbal Numerical Rating Scale (VNRS), a self-report scale ranging from 0 to 10, where 0 represents no pain and 10 corresponds to the worst pain imaginable.
Time frame
Assessments will be conducted at baseline (T0), 2 minutes after the intervention (T2), and one week post-intervention (T3). The T3 assessment will be performed by a research assistant.2
Anxiety intensity
Anxiety intensity will be assessed using a validated self-report scale (VNRS) ranging from 0 to 10, where 0 signifies no anxiety and 10 indicates the highest possible level of anxiety.
Time frame
Measurements will be taken at baseline (T0), 2 minutes after the intervention (T2), and one week later (T3). The T3 evaluation will be conducted by a research assistant through the participant's preferred mode of communication.3
Change in heart rate
Change in heart rate (beats per minute) will be measured by using COVIDIEN Nellcor pulse oxygen saturation meter, an approved and validated device (T0, T2).
Time frame
Heart rate (beats per minute) will be measured right before the procedure, at baseline (T0) and about 2 minutes after the end of the hysteroscopy procedure (T2).4
Failure of hysteroscopy
Failure of hysteroscopy will be assessed by recording the number of procedures that are not completed as intended or that require rescheduling.
Time frame
To be reported during the procedure (T1)Sponsors and contacts
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Source ClinicalTrials.gov