Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy

NCT06463210 | Completed

• 1 other identifier: VRHSC 21/278
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Acute; Satisfaction, Patient

Keywords

Hysteroscopy

Outcome Measures

Primary Outcomes (2)

• Peak pain

  a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable

  5-10 minutes after the procedure

• Mean pain

  a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable

  5-10 minutes after the procedure

Secondary Outcomes (4)

• Patient satisfaction with the information received

  5-10 min before the procedure

• Patient overall satisfaction with the procedure (OH)

  5-10 min after the procedure

• Patient satisfaction with the VR intervention

  5-10 min after the procedure

• Patient satisfaction with the VR intervention

  5-10 min after the procedure

Study Arms (2)

Nurse support during hysteroscopy: control group

NO INTERVENTION

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.

Virtual reality during hysteroscopy: study group

EXPERIMENTAL

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

Device: Virtual reality as a distraction technique

Interventions

Virtual reality as a distraction technique DEVICE

A 360º relaxing video with music was displayed through a VR headset

Virtual reality during hysteroscopy: study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Related Publications (9)

• 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.

  PMID: 37648150 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38165441 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37297840 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34748679 BACKGROUND

• 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.

  PMID: 33027546 BACKGROUND

• 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.

  PMID: 40400089 DERIVED

MeSH Terms

Conditions

Acute Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants or care providers was not feasible to implement due to the nature of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 randomized groups with 60 patients per arm

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 5, 2024

Record last verified: 2024-06

Locations

ES (1)