AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Procedural Anxiety
研究概览
简要总结
The goal of this clinical trial is to learn about the reduction of pain and anxiety during a minor procedure in the emergency department on adult patients through the visualisation of atmospheric projection as a distraction mean. The main question it aims to answer is :
Can the atmospheric projection of a video reduce pain and anxiety in adult patients receiving painful procedures in the emergency department ?
Participants will look at an atmospheric projection (projection of a media on the walls and roof around the patient) while receiving their planned care procedures. Researchers will compare an active group watching a video with a control group watching a simple colored light to see if the visualisation of an atmospheric projected video reduces pain and anxiety more than the visualisation of a colored light does.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient will assess the outcome him/herself. The statistician will also be blinded to the group assignment.
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
- •Aged ≥18 ;
- •Patient requiring one of the following treatment procedures : suturing, plaster cast placement and/or repositioning, fracture or dislocation reduction, ascites puncture, pleural puncture, lumbar puncture.
排除标准
- •Patient clinically unstable;
- •Patient incapable of discernment or consent ;
- •Altered mental status (cognitive disorders, mental retardation, acute state of confusion, acute psychosis);
- •Alcoholic patient with University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score of 10/10 ;
- •Patient hard of hearing ;
- •Patient with visual impairments preventing him/her from perceiving his/her environment ;
- •Patient unable to understand the use of visual analog scales (VAS);
- •Impaired sensitivity of the part of the body where the medical intervention is to take place;
- •Planned use of analgesia/sedation with a dissociative agent (midazolam, ketamine, propofol);
- •Incarcerated patient ;
- •Patient transferred from another hospital ;
- •Patient having already participated in this study during a previous consultation in the emergency department of the Centre Hospitalier Universitaire Vaudois.
结局指标
主要结局
Procedural Anxiety
时间窗: Just after the procedure
Maximal anxiety intensity felt by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "Not at all anxious/Extremely anxious."
Procedural Pain
时间窗: Just after the procedure
Maximal pain intensity experienced by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "No pain/Worst pain imaginable"
次要结局
- Cybercinetosis(Just after the procedure)
- Appreciation of the atmospheric projection(Just after the procedure)
- Dissociation(Just after the procedure)
- Patient's comfort(Just after the procedure)
- Telepresence(Just after the procedure)
- Procedural support(After the procedure)
- Procedural disturbance(Just after the procedure)
- Pain catastrophizing(Just before the procedure)
研究者
Olivier Hugli
Head of Emergency Department
University of Lausanne Hospitals