HysteroscopyVR-HYSTERONCT07173231
Use of VR for Diagnostic Hysteroscopy
A study testing Immersive Virtual Reality Distraction (IVR) and Hypno-Virtual Reality Distraction (HVR) in people with Hysteroscopy and Anxiety, run by St. Justine's Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysteroscopy, Anxiety, Pain
- What is being tested?
- Immersive Virtual Reality Distraction (IVR) and Hypno-Virtual Reality Distraction (HVR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2026to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 18 years old
- Speak and read French or English
- Scheduled to undergo a diagnostic hysteroscopy
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine Hospital
Montreal, Quebec, H3T 1C5
Sylvie Le May, RN, PhD, FCAN, 1-514-345-4931 ext. 4938, sylvie.lemay@umontreal.ca
sylvie.lemay@umontreal.ca
About this study
Official title: Comparisons Between Virtual Reality and Hypno-Virtual Reality for Procedural Pain and Anxiety During a Diagnostic Hysteroscopy: A Pilot Randomized Controlled 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.
Read more
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
- Being tested
- Immersive Virtual Reality Distraction (IVR), Hypno-Virtual Reality Distraction (HVR), Usual Care Group
- Keywords
- women's health, hysteroscopy, anxiety, procedural pain
- Medical subject headings
- Anxiety Disorders, Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality Distraction (IVR)Device
The 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)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.
Usual Care GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Distraction (IVR) | Experimental | Use of IVR during diagnostic hysteroscopy Receives: Device: Immersive Virtual Reality Distraction (IVR) |
| Hypno-Virtual Reality distraction (HVR) | Experimental | Use of HVR during diagnostic hysteroscopy Receives: 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 Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: To be reported at the end of the intervention, about 2 minutes after the end of the hysteroscopy procedure (T2)
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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).
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.
Measured: To be reported during the procedure (T1)
Required time for the procedure
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.
Measured: To be reported during the procedure (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Le May, St. Justine's Hospital
- Investigators
- Sylvie Le May PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173231
- Sponsor's protocol ID
- VR-HYSTERO
- Acronym
- VR-HYSTERO
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to our REB we are not allowed to share participants' data unless there is a clear Data Sharing Agreement between parties.
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.
PubMed 32547176Lang 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.
PubMed 10801169Babbar S, Oyarzabal AJ. The Application of Hypnosis in Obstetrics. Clin Obstet Gynecol. 2021 Sep 1;64(3):635-647. doi: 10.1097/GRF.0000000000000635.
PubMed 34323237Cohen 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.
PubMed 37917158Sewell 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.
PubMed 37218438Baradwan 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. Epub 2024 Jan 2.
PubMed 38165441Deo 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.
PubMed 32575151Eijlers 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.
PubMed 31136330Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B. Virtual reality in pediatrics, effects on pain and anxiety: A systematic review and meta-analysis update. Paediatr Anaesth. 2022 Dec;32(12):1292-1304. doi: 10.1111/pan.14546. Epub 2022 Sep 1.
PubMed 35993398Paulo AAS, Solheiro MHR, Paulo COS, Afreixo VMA. What proportion of women refers moderate to severe pain during office hysteroscopy with a mini-hysteroscope? A systematic review and meta-analysis. Arch Gynecol Obstet. 2016 Jan;293(1):37-46. doi: 10.1007/s00404-015-3836-5. Epub 2015 Aug 8.
PubMed 26253336Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.
PubMed 32299254Riemma G, Schiattarella A, Colacurci N, Vitale SG, Cianci S, Cianci A, De Franciscis P. Pharmacological and non-pharmacological pain relief for office hysteroscopy: an up-to-date review. Climacteric. 2020 Aug;23(4):376-383. doi: 10.1080/13697137.2020.1754388. Epub 2020 May 12.
PubMed 32396751Ghamry NK, Samy A, Abdelhakim AM, Elgebaly A, Ibrahim S, Ahmed AA, Abdelbaky WH, Abdallah KM, Badawy MA, Mohammed AH, Hamza M. Evaluation and ranking of different interventions for pain relief during outpatient hysteroscopy: A systematic review and network meta-analysis. J Obstet Gynaecol Res. 2020 Jun;46(6):807-827. doi: 10.1111/jog.14221. Epub 2020 Feb 23.
PubMed 32088931Bracken O, Woodsmith A, Newell M. Pharmacological and non-pharmacological interventions for pain control in outpatient hysteroscopy: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2025 Mar;306:35-46. doi: 10.1016/j.ejogrb.2025.01.004. Epub 2025 Jan 5.
PubMed 39787964Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
PubMed 22387163