Anxiety, Hysteroscopy, Pain
Conditions
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
Interventions
DEVICEImmersive Virtual Reality Distraction (IVR)
The first experimental group will receive the INSPIRE® IVR intervention in addition to usual care. Developed by Paperplane Therapeutics®, INSPIRE® is specifically designed to help manage pain and anxiety in clinical settings. 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. The immersive experience is enhanced through personalized therapeutic content and calming visual and auditory stimuli, helping to reduce anxiety while minimizing the risk of cybersickness. This program has been endorsed by a multidisciplinary team of healthcare professionals.
DEVICEHypno-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. It is delivered through a validated and clinically approved HVR headset. The intervention includes reassuring and calming verbal suggestions aimed at helping participants regulate their emotions and manage anxiety throughout the procedure. Participants will be able to choose from 11 different visual scenarios, select their preferred language, and choose between a male or female voice for the hypnotic guidance. 6 different musical soundtracks will also be available to personalize the experience more.
OTHERUsual 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.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This pilot RCT study is mainly designed to test the feasibility and acceptability of the intervention, design and procedures. Therefore, we did not calculate a specific sample size to detect statistically significant differences. Instead, a convenience sample of 45 participants (15 per group) was selected based on established recommendations for pilot studies, which suggest that 12 participants per arm is adequate to evaluate feasibility and provide preliminary results for planning a future clinical trial (Julious, 2005). The sample size was also determined based on practical considerations related to the recruitment capacity and the study resources, as each group will include approximately 15 participants, representing about 30% of the 150 diagnostic hysteroscopy procedures performed annually at the CHU Sainte-Justine.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Contacts
Primary ContactSylvie Le May PhD
Outcome results
None listed