Benefits of Using Virtual Reality Preoperatively in Managing Anxiety During Outpatient Foot Bone Surgery (Parcours RV)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Saint-Jean, France, 31240
- Clinique de l'Union
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient with virtual reality headset
|
Watching a movie in virtual reality
satisfaction questionnaire Amsterdam Preoperative Anxiety and Information Scale Score MSP-9
|
|
Placebo Comparator: Patient with standard information about surgery
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satisfaction questionnaire Amsterdam Preoperative Anxiety and Information Scale Score MSP-9
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score of the self-questionnaire "Amsterdam Preoperative Anxiety and Information Scale" (APAIS)
Time Frame: 17 months
|
a questionnaire with 6 items and each item has a score between 1 and 5.
|
17 months
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A00921-44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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