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临床试验/NCT05963750
NCT05963750
已完成
不适用

Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 119 人2021年11月2日

概览

阶段
不适用
干预措施
virtual reality
疾病 / 适应症
Tooth Avulsion
发起方
University Hospital, Caen
入组人数
119
试验地点
1
主要终点
effectiveness of virtual reality on anxiety (STAI-YA)
状态
已完成
最后更新
2个月前

概览

简要总结

Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. There is a group with virtual reality and a control group without virtual reality.

Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA score before vs during the surgery. Secondary criteria are the relevance of the chosen metric by comparing it to the VAS, defining the factors influencing the evolution of the anxiety score, studying the side effects of VR and the wish to repeat the experience.

详细描述

The virtual reality experience consisted of putting on a headset with music and a 3D helmet on the eyes that broadcast a landscape in motion (a walk). The inclusion took place in the University Hospital of Caen between november 2021 and may 2022. 119 patients were randomized into two groups, one with VR and another one without VR. At the end, 105 patients were analyzed. The main objective was to find a reduction in the STAI-YA score of more than 8 points between before and during the intervention. This analysis was performed in both groups. During the initial consultation, questions were asked about the medical file and informed consent was sought. Patients were then randomised to one of two groups. During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress experienced during the surgery.

注册库
clinicaltrials.gov
开始日期
2021年11月2日
结束日期
2022年7月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • \- Adults (\> 18 years old) coming for at least two dental extractions under local anesthesia

排除标准

  • patients suffering of motion sickness,
  • claustrophobia,
  • uncontrolled epilepsy,
  • visual impairment,
  • hearing disability,
  • non-French speakers,
  • pregnant women,
  • protected adults
  • people followed by a psychiatrist whether for depression, bipolarity, schizophrenia
  • The day of the intervention, patients who had consumed anxiolytics

研究组 & 干预措施

virtual reality during the surgery

Group with the use of virtual reality during the surgery

干预措施: virtual reality

control

Group without the use of virtual reality during the surgery

结局指标

主要结局

effectiveness of virtual reality on anxiety (STAI-YA)

时间窗: Baseline and during the procedure.

The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.

effectiveness of virtual reality on anxiety (Visual Analogue Scale)

时间窗: Baseline and during the procedure.

The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.

次要结局

  • factors influencing changes in the STAI-YA anxiety score(1 day of surgery)
  • Comparability of the results with another metric for assessing anxiety(1 day of surgery)
  • The wish to renew the virtual reality experience(1 day of surgery)

研究点 (1)

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