TerminatedNot Applicable

Benefits of Using Virtual Reality Preoperatively in Managing Anxiety During Outpatient Foot Bone Surgery

Stopped: Inclusion difficulties

France19 participantsStarted 2023-12-20

Plain-language summary

Forefoot bone surgeries, such as surgical correction of hallux valgus, are routine orthopedic procedures. Outpatient surgery is offered in the vast majority of cases with regional anesthesia. Even though it is a simple and quick surgical procedure, it affects the patient's body image, who will worry about the outcome. Furthermore, because the anesthesia is regional, the patient can hear the surgical procedures being performed, which generates anxiety. Finally, the lack of information about the preoperative process, from arrival at the hospital and then in the ward to the operating room, can generate additional anxiety for the patient. One way to reduce anxiety related to surgery could be the use of virtual reality (VR) techniques. VR uses technologies that simulate a user's physical presence in an environment artificially generated by software. VR has already been used in studies to distract patients from pain and stress. During surgery, wearing a VR headset can reduce anxiety and stress related to the procedure. However, there are currently few studies investigating the use of VR to reduce preoperative anxiety and postoperative pain. This research is based on the hypothesis that visualizing the perioperative journey via a VR headset, some time before the procedure, would reduce preoperative anxiety and postoperative pain. The main objective is to evaluate the effect of using virtual reality on preoperative anxiety, through the visualization of a virtual perioperative journey by patients before surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient aged 18 years or older at the time of study enrollment * Patient hospitalized for scheduled outpatient forefoot bone surgery with regional anesthesia * Patient capable and willing to follow the protocol procedures as directed by the investigator * Patient with a compatible smartphone * Patient with a personal email address * Patient affiliated with or covered by a social security plan * Patient who has given their free, informed, and explicit written consent Exclusion Criteria: * Patient with a contraindication to regional anesthesia * Emergency patient * Epileptic patient * Patient with significant visual impairment or uncorrected strabismus * Patient with a cognitive barrier (dementia, major psychiatric disorders, etc.) * Patient taking medication for stress or anxiety (benzodiazepines, anxiolytics, antidepressants, etc.) or analgesics chronically * Patient with agoraphobia * Patient with a history of motion sickness, vertigo, or vestibular neuritis * Patient who does not understand or speak French * Pregnant, breastfeeding, or parturient patient * Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Score of the self-questionnaire "Amsterdam Preoperative Anxiety and Information Scale" (APAIS)

Timeframe: 17 months

Trial details

NCT IDNCT07639320

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-14

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