Clinical trial NCT06463210: Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy
Official title: Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Satisfaction, Patient
Keywords: Hysteroscopy
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 randomized groups with 60 patients per arm
Primary purpose: TREATMENT

Brief summary: The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

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

Detailed description: The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

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.

Eligibility criteria: Inclusion Criteria:

* Consecutive women candidates to undergo an OH
* Women aged 18 to 70 years old

Exclusion Criteria:

* Visual impairment
* 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

Primary outcomes:
measure: Peak pain
timeFrame: 5-10 minutes after the procedure
measure: Mean pain
timeFrame: 5-10 minutes after the procedure
Secondary outcomes:
measure: Patient satisfaction with the information received
timeFrame: 5-10 min before the procedure
measure: Patient overall satisfaction with the procedure (OH)
timeFrame: 5-10 min after the procedure
measure: Patient satisfaction with the VR intervention
timeFrame: 5-10 min after the procedure
measure: Patient satisfaction with the VR intervention
timeFrame: 5-10 min after the procedure
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Comunidad De Madrid
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.