Preoperative AnxietyOpeZenNCT07530120
Effect of 360° VR and 2D Videos on Patient Anxiety in Outpatient Ophthalmologic Care
A study testing Watching a video of the outpatient care pathway and No viewing of the video in people with Preoperative Anxiety and Virtual Reality, run by Institut Ophtalmologique de l'Ouest Jules Verne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Preoperative Anxiety, Virtual Reality
- What is being tested?
- Watching a video of the outpatient care pathway and No viewing of the video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 9 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Ophtalmologique de l'Ouest Jules Verne
Nantes, Loire Atlantique, 44300
About this study
Official title: 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.
Read the 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.
- Conditions
- Preoperative Anxiety, Virtual Reality
- Being tested
- Watching a video of the outpatient care pathway, No viewing of the video
- Keywords
- Video 2D, 360° video, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching a video of the outpatient care pathwayOther
Also called 2D-V, VR
Before surgery, patients watch an informational video explaining the outpatient journey at IOO Jules Verne.
No viewing of the videoOther
Also called Control
The control group does not view the video and receives only verbal information delivered by the administrative staff.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Watching a video of the outpatient care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Day 1 (postoperative assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Oct 2024
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Ophtalmologique de l'Ouest Jules Verne
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University
- Responsible party
- Sponsor
- Investigators
- Frank BECQUET, Docteur, Principal investigator, Institut Ophtalmologique de l'Ouest Jules VerneJean Philippe RIVIERE, Maître de conférences, Study director, Laboratoire des Sciences du Numérique de Nantes UMR-6004
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530120
- Sponsor's protocol ID
- IRB : IORG0011023
- Acronym
- OpeZen
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences Between a 360-VR Video and a 2D-video in Reducing Anxiety in an Ophtalmological Ambulatory Care Pathway
- ClinicalTrials.gov ID
- NCT07530120
- Acronym / sponsor ID
- OpeZen / IRB : IORG0011023
- Conditions
- Preoperative Anxiety, Virtual Reality
- Keywords
- Video 2D, 360° video, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Institut Ophtalmologique de l'Ouest Jules VerneUniversity, hospital or other
- Collaborators
- Nantes University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Control : NON | Placebo comparator | Other: No viewing of the videoNON (Baseline): Control condition providing no video to the patients. This is what patients really lived routinely in the ophthalmological ambulatory pathway. |
| Group Video : 2D-V | Active comparator | Other: Watching a video of the outpatient care pathwayVideo: NON condition with the watching of a 2D video ~1month before the surgery. |
| Group Virtual Reality : VR | Active comparator | Other: Watching a video of the outpatient care pathwayVR: NON condition with watching of a 360-VR video corresponding to a 360 video of the ophthalmological ambulatory pathway |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
- Any medical condition preventing immersion in virtual reality (e.g., epilepsy, dizziness/vertigo, psychiatric history, use of medication or substances with psychoactive effects, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watching a video of the outpatient care pathwayAlso: 2D-V, VRBefore surgery, patients watch an informational video explaining the outpatient journey at IOO Jules Verne. | Other | Group Video : 2D-V, Group Virtual Reality : VR |
| No viewing of the videoAlso: ControlThe control group does not view the video and receives only verbal information delivered by the administrative staff. | Other | Group Control : NON |
Primary outcome
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).
1 secondary outcome
Anxiety, quality of information, and disorientation during hospitalization and the ambulatory pathway
Time frame: Day 1 (postoperative assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank BECQUET, Docteur principal investigator
Institut Ophtalmologique de l'Ouest Jules Verne
Jean Philippe RIVIERE, Maître de conférences study director
Laboratoire des Sciences du Numérique de Nantes UMR-6004
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching a video of the outpatient care pathway and No viewing of the video in people with Preoperative Anxiety and Virtual Reality, run by Institut Ophtalmologique de l'Ouest Jules Verne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with reduced preoperative anxiety compared to baseline (time frame: Baseline (preoperative consultation) and Day 1 (preoperative assessment before surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.