Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy

July 2, 2024 updated by: Hospital Universitario 12 de Octubre

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Comunidad De Madrid
      • Madrid, Comunidad De Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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
Device: Virtual reality as a distraction technique
A 360º relaxing video with music was displayed through a VR headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak pain
Time Frame: 5-10 minutes after the procedure
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
Time Frame: 5-10 minutes after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the information received
Time Frame: 5-10 min before the procedure
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
Patient overall satisfaction with the procedure (OH)
Time Frame: 5-10 min after the procedure
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
Patient satisfaction with the VR intervention
Time Frame: 5-10 min after the procedure
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
Patient satisfaction with the VR intervention
Time Frame: 5-10 min after the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRHSC 21/278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If needed for further studies and with the previous evaluation of the investigators IPD would be available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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