Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Digital visual scale to assess anxiety of patients during the treatment
研究概览
简要总结
The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.
详细描述
Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation.
The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patient with medical insurance
- •Major patient requiring a Hallux Valgus surgery
- •Patient who received information about study and signes a consent to participate in the study
排除标准
- •Minor patient
- •Patient participating in another interventional study
- •Patient refusing to sign the consent form
- •Patient for whom it is impossible to give informed information
- •Patient who had previously undergone forefoot surgery under locoregional anesthesia
- •Patient with poor skin condition or infection at puncture sites
- •Patient refusing locoregional anesthesia
- •Patient under the protection of justice, under curatorship or under tutorship
- •Patient undergoing anxiolytic or antidepressant treatment
- •Photosensitive epileptic patient
研究组 & 干预措施
Virtual reality
The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
干预措施: Virtual reality (Device)
Drug sedation
The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.
干预措施: Droleptan (Drug)
Drug sedation
The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.
干预措施: Propofol (Drug)
Drug sedation
The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.
干预措施: Sufentanyl (Drug)
结局指标
主要结局
Digital visual scale to assess anxiety of patients during the treatment
时间窗: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety
Digital visual scale to assess pain of patients during the treatment
时间窗: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain
次要结局
- Patient comfort assessment questionnaire(5 min after the last nerve punction)
- Patient satisfaction questionnaire(5 min after the last nerve punction)