Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy

Pain, Acute Clinical Trial

Official title:

Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06463210
• Other study ID #: VRHSC 21/278
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2024
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We 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.

We wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH

Description:

We 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 We 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Consecutive women candidates to undergo an OH were invited to participate in the trial. Inclusion criteria was limited to women aged 18 to 70 years who were planned for OH

Exclusion Criteria:

• Women with visual or hearing impairment, language barrier impeding the correct explanation of the study, contraindication for using the VR device, confirmed malignant endometrial disease or with anatomical characteristics impeding the office hysteroscopy were excluded

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Satisfaction, Patient

Intervention

Device:
• Virtual reality as a distraction technique
A 360º relaxing video with music was displayed through a VR headset

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid	Comunidad De Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak pain	a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure	5-10 minutes after the procedure
Primary	Mean pain	a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure	5-10 minutes after the procedure
Secondary	Patient satisfaction with the information received	Prior to the OH all patients were interrogated about their perception of the information received about the procedure through the question "How has been the information received about the procedure?" (Not enough/Normal/Very good	5-10 min before the procedure
Secondary	Patient overall satisfaction with the procedure (OH)	Overall satisfaction with the OH was assessed through a question formulated as follows: "What is your level of satisfaction with the hysteroscopic procedure?", where patients could evaluate their opinion on a 5-point scale (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied	5-10 min after the procedure
Secondary	Patient satisfaction with the VR intervention	On the study group, patient satisfaction with the VR intervention was also assessed with the following 5-point scale satisfaction question "What is your level of satisfaction with the VR intervention? (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied	5-10 min after the procedure
Secondary	Patient satisfaction with the VR intervention	Patients on the VR group were also asked whether they would like to use the VR if they need to undergo another OH in the future (Yes/No)	5-10 min after the procedure