Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Variation of intensity of the 5 discomfort symptoms (pain, anxiety, thirst, dyspnea, insomnia) assessed by a self-report 0-10 visually enlarged numeric rating scale
研究概览
简要总结
This is a feasibility study of electronic devices in order to reduce neuro-psychological disorders and suffering in intensive care unit (ICU) patients. A first step study is necessary to define which device is effective and safe to reduce symptom intensities, among music therapy, virtual reality with real pictures, virtual reality with artificial pictures, and common devices (radio or television). If some devices are effective to reduce patients' symptoms, a second step will be to implement and assess the impact of these tools in a multicenter trial.
详细描述
Quality of life following intensive care unit discharge is more and more anticipated during the ICU stay. Psychological trauma during ICU stay, related to medical management, can be very deleterious at short and long term, inducing psychological troubles as post-traumatic stress disorder and delaying the return to a normal social and professional life. For this reason, managing patients' distress is particularly important in the intensive care setting. There has been an increasing number of new technologies for the distraction of patients in different settings. a Today, a large amount of electronic distraction is available. TV and radio are available in each ICU, music therapy has already been studied and it is currently used in some ICUs. Virtual reality (VR) is used to improve attention and memory in stroke patients. Furthermore, VR seems to decrease stress post trauma disorders and phobia, as well as pain and anxiety during surgical procedures and physiotherapy. Our first step study will help us to determine which electronic distraction has the most effect on the top five discomfort symptoms frequently observed in ICU: pain, anxiety dyspnea, thirst and sleep privation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 admitted in intensive care unit,
- •French speaking,
- •awake (RASS ≥ -1),
- •not delirious (CAM-ICU negative),
排除标准
- •patient refusal
- •psychosis or preexisting cognitive dysfunction
- •cerebral injury,
- •hygiene/microbiological harm,
- •pregnancy,
- •decision of withdrawal of care
研究组 & 干预措施
Virtual reality with computer graphics
Use of Virtual reality with computer graphics
干预措施: CHOISIR (Other)
Virtual reality with real movies
Use of Virtual reality with real movies
干预措施: CHOISIR (Other)
Music therapy (dedicated device and music scores)
Use of music therapy (dedicated device and music scores)
干预措施: CHOISIR (Other)
Usual device (TV radio)
usual distraction : watching TV
干预措施: CHOISIR (Other)
结局指标
主要结局
Variation of intensity of the 5 discomfort symptoms (pain, anxiety, thirst, dyspnea, insomnia) assessed by a self-report 0-10 visually enlarged numeric rating scale
时间窗: Just after the use of each device (up to 20 minutes)
次要结局
- Variation of physiologic Blood pressure during the use of each device(up to 20 minutes (after the device use ))
- Variation of Respiratory rate during the use of each device(up to 20 minutes (after the device use ))
- Variation of physiologic parametres (Heart Rate, Blood pressure, Respiratory rate and Analgesia nociception Index), evaluation of feasibility and feelings concerning the distraction devices.(ICU discharge (up to Day 28))
- Variation of Heart Rate during the use of each device(up to 20 minutes (after the device use ))
- evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10(just after the use of each device (up to 20 minutes))
- Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10(ICU discharge or up to Day 28)