Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy
NCT ID: NCT06463210
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2022-01-01
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.
The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial
NCT04802460
Virtual Reality to Improve Satisfaction in Hysteroscopy Patients
NCT04862598
Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy
NCT06424093
Virtual Reality and Outpatient Hysteroscopy
NCT03699280
Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy
NCT04721587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
The standard care group had a trained nurse providing distraction and emotional support.
The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nurse support during hysteroscopy: control group
In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
As part of our standard procedure during the OH, a trained nurse with \>10 years of experience provides distraction and emotional support to the woman. She explains the patient how to breathe and what to expect during the different moments of the procedure, thus involving the women directly in what is happening during the procedure.
No interventions assigned to this group
Virtual reality during hysteroscopy: study group
In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
A 360º video was administered to the study group through an Oculus Quest 2™ headset (Meta Platforms, CA. USA). The video was administered through the headset just before the start of the procedure. The video chosen showed a gondola ride through the canals of Venice with relaxing music played on the headset
Virtual reality as a distraction technique
A 360º relaxing video with music was displayed through a VR headset
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual reality as a distraction technique
A 360º relaxing video with music was displayed through a VR headset
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women aged 18 to 70 years old
Exclusion Criteria
* Hearing impairment
* Language barrier impeding the correct explanation of the study
* Contraindication for using the VR device
* Confirmed malignant endometrial disease
* Anatomical characteristics impeding the office hysteroscopy
18 Years
70 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario 12 de Octubre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vitagliano A, Dellino M, Favilli A, D' Amato A, Nicoli P, Lagana AS, Noventa M, Bochicchio MA, Cicinelli E, Damiani GR. Patients' Use of Virtual Reality Technology for Pain Reduction during Outpatient Hysteroscopy: A Meta-analysis of Randomized Controlled Trials. J Minim Invasive Gynecol. 2023 Nov;30(11):866-876. doi: 10.1016/j.jmig.2023.08.427. Epub 2023 Aug 29.
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.
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. Epub 2024 Jan 2.
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.
Pelazas-Hernandez JA, Varillas-Delgado D, Gonzalez-Casado T, Cristobal-Quevedo I, Alonso-Bermejo A, Ronchas-Martinez M, Cristobal-Garcia I. The Effect of Virtual Reality on the Reduction of Pain in Women with an Indication for Outpatient Diagnostic Hysteroscopy: A Randomized Controlled Trial. J Clin Med. 2023 May 24;12(11):3645. doi: 10.3390/jcm12113645.
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.
Fouks Y, Kern G, Cohen A, Reicher L, Shapira Z, Many A, Yogev Y, Rattan G. A virtual reality system for pain and anxiety management during outpatient hysteroscopy-A randomized control trial. Eur J Pain. 2022 Mar;26(3):600-609. doi: 10.1002/ejp.1882. Epub 2021 Nov 23.
Mirza E, Hanif M, Khan MA, Jaleel S. Re: Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Mar;128(4):769-770. doi: 10.1111/1471-0528.16500. Epub 2020 Oct 7. No abstract available.
Olloqui A, Tejerizo-Garcia A, Guillen C, Perez-Sagaseta C, Gonzalez-Macho C, Bolivar-Miguel AB, Villalba-Gutierrez A, Gil-Ibanez B. Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: A Randomised Controlled Trial. BJOG. 2025 Sep;132(10):1416-1425. doi: 10.1111/1471-0528.18228. Epub 2025 May 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VRHSC 21/278
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.