Effect of 360° VR and 2D Videos on Patient Anxiety in Outpatient Ophthalmologic Care (OpeZen)

Differences Between a 360-VR Video and a 2D-video in Reducing Anxiety in an Ophtalmological Ambulatory Care Pathway

Background Previous research on ambulatory care pathways has highlighted recurring issues such as elevated patient anxiety, disorientation, and insufficient access to information, all of which negatively affect the patient experience. However, evidence remains limited regarding the effectiveness of different preparatory media in mitigating these issues in real-world clinical settings.

Objectives The present study aims to assess whether viewing a video of an outpatient ophthalmologic care pathway prior to the day of surgery-either as a standard 2D video or as a 360° immersive video experienced in virtual reality (VR)-reduces patient anxiety and disorientation compared with a control condition without media support. In addition, the study aims to determine which medium is most effective and to explore methods for assessing anxiety, orientation, and information in ecological clinical settings.

Study Overview

Detailed Description

Background Previous research on ambulatory care pathways has identified recurring issues such as high patient anxiety, disorientation, and insufficient information, all of which negatively impact the patient experience. However, evidence remains limited regarding how different preparatory media may effectively mitigate these factors in real clinical settings.

Objectives The present study aims to assess whether viewing a video of an outpatient ophthalmologic pathway prior to the day of surgery-either as a conventional 2D video or as a 360° immersive video experienced in virtual reality (VR)-reduces patient anxiety and disorientation compared with a control condition without media support. In addition, the study aims to determine which medium is most effective and to explore how anxiety, orientation, and information can be assessed in ecological clinical settings.

An in-the-wild user study is planned with approximately 180 patients undergoing outpatient ophthalmologic surgery. Participants will be assigned to one of three groups: a control group (no video), a 2D video group, or a 360° VR video group. Preoperative state anxiety will be measured using a Visual Analog Scale for Anxiety (VAS-A) at two time points: baseline (preoperative consultation) and immediately before surgery. The primary outcome will focus on the proportion of patients whose preoperative anxiety is lower than baseline anxiety. Disorientation, perception of signage, and patient information will be assessed using post-operative questionnaires. Secondary outcomes will include perceived anxiety during hospitalization, perceived quality of information, and reported feelings of disorientation during the ambulatory pathway.

Study Type

Interventional

Enrollment (Actual)

180

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

    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44300
        • Institut Ophtalmologique de l'Ouest Jules Verne

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

No

Description

Inclusion Criteria:

  • Participants should be over 18
  • Have all the cognitive and mental abilities
  • Speak french
  • Have a programmated ophthalmology surgery in outpatient
  • Have binocular corrected visual acuity > 5/10 (20/40 Snellen)

Exclusion Criteria:

  • Persons referred to in Articles L.1121-6 to L.1121-8 of the French Public Health Code (CSP) (guardianship, trusteeship, legal protection, etc.)
  • Patients undergoing surgery under general anesthesia
  • Patients undergoing emergency surgery
  • Surgery not performed within one month following the preoperative appointment (except for the control group)

For the group participating in the VR experiment:

- Any medical condition preventing immersion in virtual reality (e.g., epilepsy, dizziness/vertigo, psychiatric history, use of medication or substances with psychoactive effects, etc.)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group Control : NON
NON (Baseline): Control condition providing no video to the patients. This is what patients really lived routinely in the ophthalmological ambulatory pathway.
The control group does not view the video and receives only verbal information delivered by the administrative staff.
Other Names:
  • Control
Active Comparator: Group Video : 2D-V
Video: NON condition with the watching of a 2D video ~1month before the surgery.
Before surgery, patients watch an informational video explaining the outpatient journey at IOO Jules Verne.
Other Names:
  • VR
  • 2D-V
Active Comparator: Group Virtual Reality : VR
VR: NON condition with watching of a 360-VR video corresponding to a 360 video of the ophthalmological ambulatory pathway
Before surgery, patients watch an informational video explaining the outpatient journey at IOO Jules Verne.
Other Names:
  • VR
  • 2D-V

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with reduced preoperative anxiety compared to baseline
Time Frame: Baseline (preoperative consultation) and Day 1 (preoperative assessment before surgery)
The proportion of patients whose preoperative state anxiety (measured immediately before surgery using a Visual Analog Scale for Anxiety [VAS-A]) is lower than baseline anxiety (measured during the preoperative consultation using the VAS-A).
Baseline (preoperative consultation) and Day 1 (preoperative assessment before surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety, quality of information, and disorientation during hospitalization and the ambulatory pathway
Time Frame: Day 1 (postoperative assessment)

Patients' perceived anxiety during hospitalization, measured using Likert-scale questionnaires.

Patients' perceived quality of information, measured using Likert-scale questionnaires.

Patients' reported feelings of disorientation and perception of information during the ambulatory pathway, measured using Likert-scale questionnaires.

Day 1 (postoperative assessment)

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Frank BECQUET, Docteur, Institut Ophtalmologique de l'Ouest Jules Verne
  • Study Director: Jean Philippe RIVIERE, Maître de conférences, Laboratoire des Sciences du Numérique de Nantes UMR-6004

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)

October 1, 2024

Primary Completion (Actual)

February 9, 2026

Study Completion (Actual)

February 9, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB : IORG0011023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet decided whether individual participant data (IPD) from this study will be shared. If a decision is made not to share, it will be due to the sensitive nature of patient health information and the need to protect participant privacy.

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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