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OpenTrials
Completed

NCT Number: NCT07530120

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Ophtalmologique de l'Ouest Jules Verne

Nantes, Loire Atlantique, 44300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Watching a video of the outpatient care pathway

Other

Before surgery, patients watch an informational video explaining the outpatient journey at IOO Jules Verne.

Other names: 2D-V, VR

No viewing of the video

Other

The control group does not view the video and receives only verbal information delivered by the administrative staff.

Other names: Control

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut Ophtalmologique de l'Ouest Jules Verne

Other

Collaborators

  • Nantes University

Registry information

Official study title

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

Acronym: OpeZen

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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