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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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
hand-held fan, wristband
King's College London
King's College London
Published on BioPortfolio: 2014-07-23T21:09:04-0400
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