Use of VR for Diagnostic Hysteroscopy

Official title

Comparisons Between Virtual Reality and Hypno-Virtual Reality for Procedural Pain and Anxiety During a Diagnostic Hysteroscopy: A Pilot Randomized Controlled Trial

Overview

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

• Device Immersive 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
• Device 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. 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 throug
• Other 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 measures

• 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)]

Secondary outcome measures (6)

• Pain intensity [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.]
• Anxiety intensity [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.]
• Change in heart rate [Time frame: 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 [Time frame: To be reported during the procedure (T1)]
• Required time for the procedure [Time frame: To be reported during the procedure (T1)]
• Demographic and clinical characteristics [Time frame: Demographic and clinical characteristics will be assessed at baseline (T0)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Rousseaux F, Bicego A, Ledoux D, Massion P, Nyssen AS, Faymonville ME, Laureys S, Vanhaudenhuyse A. Hypnosis Associated with 3D Immersive Virtual Reality Technology in the Management of Pain: A Review of the Literature. J Pain Res. 2020 May 21;13:1129-1138. doi: 10.2147/JPR.S231737. eCollection 2020. PMID 32547176
• Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0. PMID 10801169
• Babbar S, Oyarzabal AJ. The Application of Hypnosis in Obstetrics. Clin Obstet Gynecol. 2021 Sep 1;64(3):635-647. doi: 10.1097/GRF.0000000000000635. PMID 34323237
• Cohen N, Nasra LA, Paz M, Kaufman Y, Lavie O, Zilberlicht A. Pain and anxiety management with virtual reality for office hysteroscopy: systemic review and meta-analysis. Arch Gynecol Obstet. 2024 Apr;309(4):1127-1134. doi: 10.1007/s00404-023-07261-9. Epub 2023 Nov 2. PMID 37917158
• Sewell T, Fung Y, Al-Kufaishi A, Clifford K, Quinn S. Does virtual reality technology reduce pain and anxiety during outpatient hysteroscopy? A randomised controlled trial. BJOG. 2023 Nov;130(12):1466-1472. doi: 10.1111/1471-0528.17550. Epub 2023 May 23. PMID 37218438
• Baradwan S, Alshahrani MS, AlSghan R, Alyafi M, Elsayed RE, Abdel-Hakam FA, Moustafa AA, Hussien AE, Yahia OS, Shama AA, Magdy AA, Abdelhakim AM, Badran H. The effect of virtual reality on pain and anxiety management during outpatient hysteroscopy: a systematic review and meta-analysis of randomized controlled trials. Arch Gynecol Obstet. 2024 Apr;309(4):1267-1280. doi: 10.1007/s00404-023-07319-8. PMID 38165441
• Deo N, Khan KS, Mak J, Allotey J, Gonzalez Carreras FJ, Fusari G, Benn J. Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Jan;128(1):87-95. doi: 10.1111/1471-0528.16377. Epub 2020 Jul 22. PMID 32575151
• Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165. PMID 31136330

Identifiers

NCT: NCT07173231 · VR-HYSTERO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗