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临床试验/NCT07639320
NCT07639320终止不适用

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

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年12月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Patient with virtual reality headset

Experimental

干预措施: Virtual reality (Other)

Patient with virtual reality headset

Experimental

干预措施: Questionnaires (Other)

Patient with standard information about surgery

Placebo Comparator

干预措施: Questionnaires (Other)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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