Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality

    Device

    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 Group

    Procedure/Surgery

    Routine preoperative procedure (local anesthesia)

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Virtual realityExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Preoperative procedure

Secondary outcomes

1

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).

Time frame
Immediately after surgery
2

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).

Time frame
15 minutes after the End of surgery
3

Intraoperative comfort

Comfort will be assessed using a simple numerical rating scale (SNR) ranging from 0 (minimum comfort) to 10 (maximum comfort).

Time frame
15 minutes after the End surgery
4

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).

Time frame
15 minutes after the End of surgery

Other outcomes

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