Refractive DisordersERVANNCT07050498
Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery
A study testing Virtual reality in people with Refractive Disorders, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Disorders
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2024to 18 Sep 2026
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older,
- Patient who has read and signed the consent form for participation in the study after a reflection period (between 10 and 45 minutes)
- Patient who is a candidate for refractive surgery
Who cannot join
- Contraindication to virtual reality (uncontrolled epilepsy, hearing impairment)
- Pregnant or breastfeeding patient
- Cushing's disease, Addison's disease, hypo- or hyperthyroidism
- Patient treated with topical or systemic corticosteroids
- Patient treated with neuroleptics, anxiolytics, or antidepressants
- Patient under legal protection, guardianship, or curatorship
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- Patient participating in another blinded research study
- Patient not affiliated with the French social security system
- Patient unable to understand the information provided and/or give written informed consent: dementia, psychosis, impaired consciousness, non-French-speaking patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Monticelli
Marseille, 13008
Louis HOFFART, MD, 04 91 16 22 22 ext. 33, louis.hoffart@me.com
Louis HOFFART, MD
About this study
The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels.
The assessment of preoperative anxiety levels will be based on the administration of a psychometric scale (APAIS scale) and the measurement of salivary cortisol, which is a sensitive marker of the patient's stress level.
Read the detailed description
This is a prospective, randomized, open-label, single-center study conducted on two parallel groups of patients undergoing refractive surgery (virtual reality preoperative conditioning or routine preoperative procedure). Therapeutic benefit is based on the assessment of preoperative anxiety using the APAIS scale.
- Conditions
- Refractive Disorders
- Being tested
- Virtual reality, Usual Care Group
- Keywords
- refractive surgery
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Virtual reality hypnosis software applications are Class I medical devices according to Rule 12 of Directive 93/42/EC. They allow, through a virtual reality headset and headphones, to immerse the patient in a hypnotic sound and visual environment. Several visual scenarios can be proposed, allowing the patient to virtually travel to a beach, the seabed, on an alpine walk, etc.).
The HypnoVR Biofeedback virtual reality device is provided by the HypnoVR company.
Usual Care GroupProcedure or surgery
Routine preoperative procedure (local anesthesia)
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia) Receives: Device: Virtual reality |
| Usual care | Active comparator | Routine preoperative procedure (local anesthesia) Receives: Procedure: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety level
The preoperative anxiety level is measured on the APAIS scale. The APAIS scale is a self-assessment consisting of six questions with expected responses rated from 1 (the patient strongly disagrees with the statement) to 5 (the patient strongly agrees with the statement) out of a minimum overall score of 6 and a maximum overall score of 30. The first three questions relate to anesthesia, and the next three relate to surgery. Of the three questions (related to anesthesia or surgery), two assess preoperative anxiety, and the third assesses the need for information.
The APAIS scale calculates four scores: overall anxiety, surgery-related anxiety, anesthesia-related anxiety, and information need. A total anxiety score of 11 or higher corresponds to a high level of anxiety.
Measured: Preoperative procedure
Secondary outcomes (14)
Intraoperative pain intensity
Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Immediately after surgery
Postoperative pain intensity
Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 15 minutes after the End of surgery
Intraoperative comfort
Comfort will be assessed using a simple numerical rating scale (SNR) ranging from 0 (minimum comfort) to 10 (maximum comfort).
Measured: 15 minutes after the End surgery
Postoperative Overall Patient Satisfaction
Overall Patient Satisfaction will be assessed using a simple numerical rating scale (SNR) ranging from 0 (not at all satisfied) to 10 (very satisfied).
Measured: 15 minutes after the End of surgery
Change in salivary cortisol
After rinsing the mouth with water, a 1 ml sample of salivary secretions without stimulation will be taken using a Salivette® (Sarstedt TM). The samples will be stored at -20°C before being analyzed by the private laboratory Eurofins, using an ELISA test (analytical sensitivity = 1.38 nmol/L; functional sensitivity = 8.28 nmol/L; upper detection limit ~110 nmol/L).
Measured: Before any study procedure
Change in salivary cortisol
After rinsing the mouth with water, a 1 ml sample of salivary secretions without stimulation will be taken using a Salivette® (Sarstedt TM). The samples will be stored at -20°C before being analyzed by the private laboratory Eurofins, using an ELISA test (analytical sensitivity = 1.38 nmol/L; functional sensitivity = 8.28 nmol/L; upper detection limit ~110 nmol/L).
Measured: Just before surgery
Change in salivary cortisol
After rinsing the mouth with water, a 1 ml sample of salivary secretions without stimulation will be taken using a Salivette® (Sarstedt TM). The samples will be stored at -20°C before being analyzed by the private laboratory Eurofins, using an ELISA test (analytical sensitivity = 1.38 nmol/L; functional sensitivity = 8.28 nmol/L; upper detection limit ~110 nmol/L).
Measured: 15 minutes after the end of surgery
Heart rate
Heart rate measurement in both groups
Measured: Before any study procedure
Blood pressure
Blood pressure measurement in both groups
Measured: Before any study procedure
Heart rate
Heart rate measurement in both groups
Measured: Before surgery
Blood pressure
Blood pressure measurement in both groups
Measured: Before surgery
Heart rate
Heart rate measurement in both groups
Measured: 15 minutes after the end of surgery
Blood pressure
Blood pressure measurement in both groups
Measured: 15 minutes after the end of surgery
Tolerance
The tolerance of the test procedure will be assessed by collecting adverse events occurring during the duration of the study.
Measured: 15 minutes after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start18 Sep 2024
- Primary completion18 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, randomized, open-label study on two parallel groups of patients
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050498
- Sponsor's protocol ID
- 2023-A01771-44
- Acronym
- ERVAN
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided