Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment of patient comfort
研究概览
简要总结
This study compares Virtual Reality versus Nitrous oxide administration for the management of anxiety and pain related to post-cardiac surgery care, especially during removal of mediastinal drainage.
详细描述
After cardiac surgery, the mediastinal and pleural drains are usually removed the second postoperative day, in the absence of complications. This procedure, realized by nurses, is a source of anxiety and pain for patients.
Nitrous oxide (Kalinox®) is commonly used to manage many situations of anxiety, including the removal of mediastinal and/or pleural drains, and has shown a greater effect than placebo in this indication.
Virtual Reality (VR) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
This randomized monocentric trial compares VR versus Kalinox® administration for the management of anxiety and pain related to post-cardiac surgery care, especially mediastinal and/or pleural drain removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Extubated after cardiac surgery
- •Sinus rhythm
- •Consent for participation
- •Affiliation to the social security system
排除标准
- •Pacemaker
- •Visual acuity making impossible the use of virtual reality
- •Intolerance to morphine
- •Contraindication to Kalinox®
- •Pregnant or breastfeeding women
- •Patients under protection of the adults (guardianship, curators or safeguard of justice)
- •Communication difficulties or neuropsychiatric disorder
研究组 & 干预措施
Kalinox®
Start of Kalinox® administration by inhalation with a facial mask 1 min before the drain removal and stop after the procedure according to the usual procedure of the service.
If Pain NRS > 4, administration of morphine.
干预措施: Kalinox (Drug)
VR
VR Installation 5 min before the drain removal and stop 10 min after the procedure.
If Pain assessed by numerical rating scale (NRS) > 4, administration of morphine.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Assessment of patient comfort
时间窗: 30 minutes
Variation of the Analgesia / Nociception Index (ANI)
次要结局
- Correlation between ANI and Anxiety NRS(30 minutes)
- Level of anxiety during drain removal(30 minutes)
- Morphine consumption(1 hour)
- Health staff satisfaction(30 minutes)
- Side effects due to Kalinox(2 hours)
- Correlation between ANI and Pain NRS(30 minutes)
- Level of pain during drain removal(30 minutes)
- Side effects due to Virtual Reality(2 hours)
- Patient satisfaction(2 hours)