Use of VR for Diagnostic Hysteroscopy
- Conditions
- HysteroscopyAnxietyPain
- Registration Number
- NCT07173231
- Lead Sponsor
- St. Justine's Hospital
- 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. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 45
- Minimum 18 years old
- Speak and read French or English
- Scheduled to undergo a diagnostic hysteroscopy
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient's acceptability towards the intervention To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) The patient's acceptability towards the intervention will be assessed using the Treatment Acceptability \& Preference (TAP) questionnaire: 10 questions (6 Likert-scale items from 0 to 4 and 4 open-ended questions). These questions focus on acceptability, satisfaction, ease of use, perceptions, and suggestions for improvement (T2).
The patient's satisfaction level 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 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).
Completion rate of the planned intervention To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) 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.
The healthcare professionals' satisfaction level To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2) 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).
Recruitment rate To be reported right before the procedure, at baseline (T0) Recruitment rate will be assessed as the proportion of patients who consent to participate out of the total number of HSC procedures performed.
- Secondary Outcome Measures
Name Time Method Anxiety intensity 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. 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.
Demographic and clinical characteristics Demographic and clinical characteristics will be assessed at baseline (T0) Demographic and clinical characteristics associated with greater benefit from the experimental interventions will be assessed by analyzing variables such as age, menopausal status, previous gynecological history, and prior experience with VR or hypnosis.
Change in heart rate Heart rate will be measured right before the procedure, at baseline (T0) and about 2 minutes after the end of the hysteroscopy procedure (T2). Change in heart rate will be measured by using COVIDIEN Nellcor pulse oxygen saturation meter, an approved and validated device (T0, T2).
Failure of hysteroscopy To be reported during the procedure (T1) Failure of hysteroscopy will be assessed by recording the number of procedures that are not completed as intended or that require rescheduling.
Required time for the procedure To be reported during the procedure (T1) Required time for the procedure will be measured in minutes, starting from the insertion of the hysteroscope intravaginally to its removal, and will be recorded by the research nurse.
Pain intensity 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. 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.