Effect of Fan Application in Preventing Ticagrelor-associated Dyspnea in Patients With Acute Coronary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Incidence of ticagrelor-associated dyspnea
研究概览
简要总结
This study will be conducted in the coronary intensive care unit of Dr. Siyami Ersek Chest, Heart and Vascular Surgery Training and Research Hospital. It aims to investigate the effect of hand fan therapy on ticagrelor-associated dyspnea in patients receiving ticagrelor.
详细描述
Patients in the coronary intensive care unit receiving ticagrelor and meeting the inclusion criteria will be included. The study includes two groups: a control group receiving standard care and an experimental group receiving standard care plus hand fan therapy. A total of 110 participants (55 per group) will be recruited. Randomization will be performed using a computer-based randomization program. Due to the nature of the intervention and sample characteristics, participants and the researcher will not be blinded. Data will be analyzed by a statistician not involved in the study, and the findings will be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be assessed by a statistician not involved in the study. Participants and researchers will not be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 65,
- •No severe hearing and vision problems,
- •Can speak and understand Turkish,
- •Easy to communicate with,
- •First-time sufferer of acute coronary syndrome (ACS) for the first time,
- •Decided to start ticagrelor therapy,
- •Able to adapt to treatment,
- •Individuals who volunteered to participate in the research.
排除标准
- •Having any problem that prevents you from communicating cognitively, emotionally and verbally,
- •Obstructive sleep abnormalities,
- •Have a disease that affects respiratory function (stage IV cancer, bronchial asthma, COVID-19, lung cancer, pulmonary edema, chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, pneumonia or bronchitis, etc.),
- •With metabolic abnormalities,
- •Intubated after the procedure,
- •Previously treated with ticagrelor,
- •Individuals who did not volunteer to participate in the study. Losses to follow up
- •Individuals who wish to leave the study voluntarily.
- •Saturation value below 95%,
- •The one with the arrest,
- •Who will not be able to fulfill the requirements of the work,
- •Individuals with life-threatening conditions
结局指标
主要结局
Incidence of ticagrelor-associated dyspnea
时间窗: Time Frame: 0-120 minutes after ticagrelor administration (T1: baseline; T2: 30 min; T3: 60 min; T4: 120 min) Unit of Measure: Percentage of participants (%)
The proportion of participants who experience dyspnea within 120 minutes following ticagrelor administration will be recorded.
次要结局
- Time to onset of ticagrelor-associated dyspnea(Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min))