NCT07530120

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

February 9, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

Video 2D360° videoVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with reduced preoperative anxiety compared to baseline

    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 Outcomes (1)

  • Anxiety, quality of information, and disorientation during hospitalization and the ambulatory pathway

    Day 1 (postoperative assessment)

Study Arms (3)

Group Control : NON

PLACEBO COMPARATOR

NON (Baseline): Control condition providing no video to the patients. This is what patients really lived routinely in the ophthalmological ambulatory pathway.

Other: No viewing of the video

Group Video : 2D-V

ACTIVE COMPARATOR

Video: NON condition with the watching of a 2D video \~1month before the surgery.

Other: Watching a video of the outpatient care pathway

Group Virtual Reality : VR

ACTIVE COMPARATOR

VR: NON condition with watching of a 360-VR video corresponding to a 360 video of the ophthalmological ambulatory pathway

Other: Watching a video of the outpatient care pathway

Interventions

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

Also known as: Control
Group Control : NON

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

Also known as: 2D-V, VR
Group Video : 2D-VGroup Virtual Reality : VR

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Ophtalmologique de l'Ouest Jules Verne

Nantes, Loire Atlantique, 44300, France

Location

Study Officials

  • Frank BECQUET, Docteur

    Institut Ophtalmologique de l'Ouest Jules Verne

    PRINCIPAL INVESTIGATOR
  • Jean Philippe RIVIERE, Maître de conférences

    Laboratoire des Sciences du Numérique de Nantes UMR-6004

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The primary objective of this research is to evaluate the effectiveness of a 360° video, presented in Virtual Reality, in enhancing patient information and reducing anxiety and disorientation among patients undergoing outpatient ophthalmology surgery, compared to a traditional 2D video and a baseline condition with no media intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

April 15, 2026

Study Start

October 1, 2024

Primary Completion

February 9, 2026

Study Completion

February 9, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations