The Influence of Non-pharmacological Medical Approaches Such as Hypnosis and Virtual Reality to Reduce Pain and Anxiety Before and After a Cardiovascular Surgery. A Randomized Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
Nowadays, the use of cognitive behavioral therapies has become quite common in the clinical care. Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of acute and chronic pain (Pourmand et al., 2017; Vanhaudenhuyse et al., 2009). A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception.
100 patients who are undergoing a cardiovascular surgery at the Liège University Hospital will be randomly assigned to four conditions (control, hypnosis, VR and VRH). Each participant will receive two sessions of one of the techniques: one the day before the surgery and one other session the day after, in intensive care units.
Physiological parameters will be taken and participants will fill in a questionnaire which evaluates their level of perceived immersion, their level of anxiety, fatigue, pain and relaxation. A short interview will also be conducted to give participants the opportunity to openly describe their experience.
This study will help to expand the knowledge regarding the influence of these techniques on patient's cognition, perception and sensation .
详细描述
Primary outcome (anxiety) and secondary outcomes (pain, fatigue, relaxation and physiological parameters) will be investigated at four measurement times: the day before the surgery (Day -1) before the intervention (T0: baseline) and after the intervention (T1); the day after the surgery (Day+1) before the intervention (T2) and after (T3).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing cardiac surgery
- •Who have given consent for their participation.
排除标准
- •Psychiatric antecedents
- •Claustrophobia
- •Acrophobia,
- •Heavy hearing
- •Visual impairment
- •Infectious cases (example: conjunctivitis)
结局指标
主要结局
Anxiety
时间窗: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
Pain perception
时间窗: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.
次要结局
- Physiological parameters(Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention))
- Relaxation(Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention))
- Fatigue(Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention))
研究者
Audrey Vanhaudenhuyse
PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department
University of Liege