Effectiveness of Multimedia Content Exposure in Improving the Experience and Reported Patient Outcomes in Patients Suffering From Acute Mycardial Infarction During the Transfer to Hospital: a Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Anxiety state
研究概览
简要总结
Randomised clinical trial, single-center, blinded assessment, controlled with standard practice with two-group parallel design.
Eligible patients are those assisted and transferred suffering from ST-Elevation myocardial infarction in an Advanced Life Support ambulance from an public Emergency Medical Service in the Cadiz area (Spain).
Experimental group will watch an ad hoc design multimedia content in a tablet (video with sound and subtitles) during the transfer and control group will be assisted as standard procedures.
Main outcome variables will be conformed by patient reported outcomes (anxiety State, pain and comfort) and patient experience (transfer experience).
详细描述
Due to intrinsic characteristics of ambulance transport raises stress or anxiety in patients. Moreover, other outcomes such as pain and some specific vital signs are affected. In the last years, empowerment patient strategies have been launched in several clinical settings but none in the ER field.
Main objective Comparative assessment of the effectiveness of multimedia exposure vs standard clinical procedures to improve the experience and patient reported outcomes in patients suffering from ST-Elevation myocardial infarction transferred to hospital in an Advanced Life Support ambulance for a percutaneous coronary intervention (PCI).
Methods Randomised clinical trial, single-center, blinded assessment, controlled with usual practice with two-group parallel design.
Eligible patients are those assisted and transferred suffering from STEMI in an Advance Life Support (ALS) ambulance from public Emergency Medical System in the Cadiz region.
Experimental group will watch multimedia content on a tablet (movie or image with sound) ad hoc designed, control group will be assisted as usual procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization variable encoding will be blinded for researchers, only known by an external collaborator designed by the main researcher.
Statistical analysis will be performed by researchers who will be blinded for the assignation to experimental and control groups.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All genders patients.
- •Assisted by ALS ambulance.
- •Diagnosed with STEMI, "Killip I".
- •Transferred by an ambulance to the hospital to receive a percutaneous coronary intervention.
- •Informed consent must be signed.
- •Conscious and oriented patients.
排除标准
- •Sedation and/or assisted ventilation.
- •Blinded or visual defects.
- •Deafness.
- •Severe mental disorders or behavior disorders.
结局指标
主要结局
Anxiety state
时间窗: Minute 0.
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Anxiety state change
时间窗: Minute 10.
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Experience measure of the ambulance service
时间窗: 1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool.
Tool Ambulance Patient Reported Experience Measure (APREMS)
Comfort
时间窗: Minute 0.
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Comfort change
时间窗: Minute 10.
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
次要结局
- Pain assessment change(Minute 10.)
- Pain assessment(Minute 0.)
研究者
Sergio Cazorla Calderon
Co-Investigator; PhDc
University of Cadiz