NCT04892940已完成不适用
Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery: a Prospective Randomized Open-label Study. Virtual Reality for Analgesia in Spine Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Cumulative amount of morphine (mg) consumed for each participant.
研究概览
简要总结
The objective is to evaluate the effect of the association of virtual reality sessions with usual management on the cumulative consumption of morphine equivalent post-operatively in adolescents aged 13 to 18 years who have undergone scoliosis surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 13 and 18 years old, i.e. the age to use a virtual reality helmet according to the manufacturer's recommendations.
- •Patient with an indication for idiopathic scoliosis surgery.
- •Free, informed and signed consent by patients (or parents/parental guardians) and the investigator (no later than the day of inclusion and prior to any review required by the research)
排除标准
- •Patient undergoing surgery for neurological scoliosis.
- •Impossibility to use the VR helmet (blindness, eye infection, helmet wound, epilepsy, psychiatric or cognitive disorder incompatible with VR).
- •History of adverse effects while wearing an VR helmet (nausea, vomiting, headache, visual disturbances)
- •Patient with a contraindication to the use of morphinics
- •Patient whose both parents benefit from a legal protection measure (guardianship, curatorship, safeguard of justice)
研究组 & 干预措施
Virtual Reality group
Experimental
Adolescents aged 13 to 18 years who have undergone scoliosis surgery
干预措施: Virtual Reality (VR) technique (Device)
Virtual Reality group
Experimental
Adolescents aged 13 to 18 years who have undergone scoliosis surgery
干预措施: Analgesic protocol (Drug)
Control group
Active Comparator
Adolescents aged 13 to 18 years who have undergone scoliosis surgery
干预措施: Analgesic protocol (Drug)
结局指标
主要结局
Cumulative amount of morphine (mg) consumed for each participant.
时间窗: From day 1 to day 3 postoperatively
次要结局
- Cost-effectiveness ratio(From day 1 to day 6 postoperatively)
- Maximum level of pain assessed on a scale of 1 to 10(From day 1 to day 6 postoperatively)
- Treatment prescribed to combat the side effects of morphine(Between day 1 and day 3 postoperatively)
- daily dose of morphine(From day 1 to day 6 postoperatively)
- Morphine-related side effects(Between day 1 and day 3 postoperatively)
- Dose of treatment prescribed to combat the side effects of morphine(Between day 1 and day 3 postoperatively)
- Duration of treatment prescribed to combat the side effects of morphine(Between day 1 and day 3 postoperatively)
- Number of drug treatments as well as the purchase price of RV from a hospital perspective(From day 1 to day 6 postoperatively)
- Intensity of pain assessed on a scale of 1 to 10.(At day 3 postoperatively)
- Side effects related to the use of the virtual reality(From day 1 to day 3 postoperatively)
研究者
研究点 (1)
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