Use of VR for Diagnostic Hysteroscopy

NCT07173231 | Not Yet Recruiting

• 1 other identifier: VR-HYSTERO
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hysteroscopy; Anxiety; Pain

Outcome Measures

Primary Outcomes (5)

• 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.

  To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)

• 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.

  To be reported right before the procedure, at baseline (T0)

• 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).

  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

  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).

  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

  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).

  To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)

Secondary Outcomes (6)

• 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.

• 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.

• 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).

• Failure of hysteroscopy

  To be reported during the procedure (T1)

• Required time for the procedure

  To be reported during the procedure (T1)

Study Arms (3)

Immersive Virtual Reality Distraction (IVR)

EXPERIMENTAL

Use of IVR during diagnostic hysteroscopy

Device: Immersive Virtual Reality Distraction (IVR)

Hypno-Virtual Reality distraction (HVR)

EXPERIMENTAL

Use of HVR during diagnostic hysteroscopy

Device: Hypno-Virtual Reality Distraction (HVR)

Usual Care Treatment

ACTIVE COMPARATOR

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

Other: Usual Care Group

Interventions

Immersive Virtual Reality Distraction (IVR) DEVICE

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.

Immersive Virtual Reality Distraction (IVR)

Hypno-Virtual Reality Distraction (HVR) DEVICE

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.

Hypno-Virtual Reality distraction (HVR)

Usual Care Group OTHER

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.

Usual Care Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Related Publications (28)

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MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvie Le May PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Le May PhD

CONTACT

5143454931; sylvie.lemay@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 15, 2025
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09