Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- change of severity of breathlessness
研究概览
简要总结
Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness.
This phase II trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control.
The intervention to be tested is a HHF directed to the area of the face innervated by the second and third trigeminal nerve branches. A wristband was chosen as control under the assumption that distraction could serve as a placebo.
The main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the RCT), adherence to the study, and use and acceptance of the intervention and the control. The main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.
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
- 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 were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
- •Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
- •COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7]
排除标准
- •Unable to provide informed consent
- •Too ill to be interviewed and not fluent or illiterate in German
研究组 & 干预措施
hand-held fan
干预措施: hand-held fan (Device)
wristband
干预措施: wristband (Device)
结局指标
主要结局
change of severity of breathlessness
时间窗: between baseline and one month
次要结局
- uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)(18 months)
- change of severity of breathlessness(baseline and two months)
- use and acceptance of the intervention and the control(over 6 months)
- adherence to the study(6 months)