Effectiveness of Virtual Reality on Pain and Anxiety During the Removal of Chest Drains in Critically-ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Procedural pain score
研究概览
简要总结
Appropriate pain and anxiety management of critically-ill patients during bedside procedures remains a big challenge. Clinical Practice Guidelines recommend preemptive analgesia or non-pharmacological interventions, such as relaxation techniques or distraction, to prevent and treat pain during nursing procedures. One of the most painful procedures in the Intensive Care Unit (ICU) is the removal of chest drains in post-cardiac surgical patients.
Virtual reality (VR) is a computer-generated simulation of a 360º immersive world in which the patient can receive visual and auditory stimuli that distract them from the real environment. Current research has demonstrated that VR reduced pain and anxiety in intravenous catheter insertions or wound care.
The primary objective of the study is to evaluate the effectiveness of VR on pain and anxiety during the removal of chest drains, in post-cardiac surgical patients. The hypothesis is that VR reduces both pain and anxiety, in critically-ill patients, during the removal of chest drains in post-cardiac surgical patients.
详细描述
This is a prospective, randomized, open-label, prospective study of two parallel groups of patients during the removal of chest drains:
Group 1: removal of chest drains according to the usual management protocol.
Group 2: removal of chest drains according to the usual management protocol supplemented by the use of virtual reality glasses (VR glasses)
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
- •Patients ≥ 18 years old
- •Patients with Richmond Agitation-Sedation Scale (RASS) between -1 to RASS +1
- •Patients undergoing cardiac surgery
- •Patients with chest drains
- •Patients who voluntarily agree to participate (informed consent form)
排除标准
- •Patients with a language barrier
- •Patients with cognitive impairments
- •Patients with neuromuscular blockers
- •Patients with a previous history of documented anxiety
- •Patients with epilepsy
- •Hemodynamically unstable patients
- •Face or ocular infections, with could contaminate VR glasses
结局指标
主要结局
Procedural pain score
时间窗: 30 minutes after the removal of chest drains
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
Procedural anxiety score
时间窗: 30 minutes after the removal of chest drains
State-Trait Anxiety Inventory (STAI scale)- trait state. The anxisety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety)
次要结局
- Dose of analgesic drugs(1 hour before the procedure)
- Blood pressure(30 minutes after the removal of chest drains)
- Sociodemographic and clinical factors(Baseline)
- Respiratory rate(30 minutes after the removal of chest drains)
- Type of chest drains(At baseline)
- Number of chest drains(At baseline)
- Adverse events(30 minutes)
- Heart rate(30 minutes after the removal of chest drains)
- Type of cardiac surgery(Baseline)
- Patient satisfaction(30 minutes)
研究者
Gemma Via Clavero
PhD. Advanced Practice Critical Care Nurse
Hospital Universitari de Bellvitge