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

NCT07639320 | Terminated

• 1 other identifier: 2023-A00921-44
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Virtual Reality; Foot Surgery

Outcome Measures

Primary Outcomes (1)

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

  a questionnaire with 6 items and each item has a score between 1 and 5.

  17 months

Study Arms (2)

Patient with virtual reality headset

EXPERIMENTAL

Other: Virtual reality; Other: Questionnaires

Patient with standard information about surgery

PLACEBO COMPARATOR

Other: Questionnaires

Interventions

Virtual reality OTHER

Watching a movie in virtual reality

Patient with virtual reality headset

Questionnaires OTHER

satisfaction questionnaire Amsterdam Preoperative Anxiety and Information Scale Score MSP-9

Patient with standard information about surgery; Patient with virtual reality headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: December 20, 2023
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

FR (1)