- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530120
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Loire Atlantique
-
Nantes, Loire Atlantique, France, 44300
- Institut Ophtalmologique de l'Ouest Jules Verne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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:
|
|
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:
|
|
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:
|
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB : IORG0011023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Preoperative Anxiety
-
KU LeuvenCompletedPreoperative Anxiety | Preoperative CareBelgium
-
Sunnybrook Health Sciences CentreRecruiting
-
Cairo UniversityNot yet recruitingPreoperative Anxiety | Preoperative Anxiety Experienced by the Pediatric PatientEgypt
-
Naime YalçınEnrolling by invitationPreoperative Anxiety | Eosinophil Blood Count | STAI | Preoperative EvaluationTurkey
-
Sin Lun CHANRecruitingPreoperative AnxietyHong Kong
-
Jia-Ling WangNot yet recruiting
-
Kanuni Sultan Suleyman Training and Research HospitalRecruitingPreoperative AnxietyTurkey (Türkiye)
-
Bingol UniversityActive, not recruitingCesarean Section | Preoperative AnxietyTurkey (Türkiye)
-
Mehmet Burak EşkinRecruitingPediatric Preoperative AnxietyTurkey (Türkiye)
-
Elazıg Fethi Sekin Sehir HastanesiCompletedPreoperative Anxiety | Elective Surgery CancellationTurkey (Türkiye)
Clinical Trials on No viewing of the video
-
Second Affiliated Hospital, School of Medicine,...RecruitingDiabetic Retinopathy | Retinal Vein Occlusion | Age Related Macular Degeneration | Choroidal Neovascularization | Cystoid Macular EdemaChina
-
Oxford University Hospitals NHS TrustTerminated
-
Vanderbilt University Medical CenterNational Cancer Institute (NCI); Meharry-Vanderbilt AllianceCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
University of VermontUnited States Department of Agriculture (USDA)CompletedObesity | OverweightUnited States
-
The University of Hong KongHealth Care and Promotion Fund, Government of the Hong Kong SARCompletedUndiagnosed Psychological ProblemsHong Kong
-
Kocaeli Sağlık ve Teknoloji ÜniversitesiCompletedNursing EducationTurkey
-
University of LouisvilleKARL STORZ Endoscopy-America, Inc.CompletedFistula | Pelvic Organ Prolapse | Incontinence | Prolapse of Vaginal Vault After Hysterectomy | Bulging of Vaginal WallUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Ataturk UniversityNot yet recruitingPalliative Care | Caregiver | Relaxation Therapy