Effectiveness of a Hand-held Fan for Breathlessness
|ClinicalTrials.gov Identifier: NCT01123902|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : May 14, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Lung Cancer or Secondary Lung Metastases COPD III/IV||Device: hand-held fan Device: wristband||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Experimental: hand-held fan||
Device: hand-held fan
Patients are instructed to direct the hand-held fan towards the face around the central part of the face, the sides of the nose and above the upper lip. The hand-held fan has three soft rotor blades and an unfoldable rotor unit.
|Placebo Comparator: wristband||
Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.
- change of severity of breathlessness [ Time Frame: between baseline and one month ]
- use and acceptance of the intervention and the control [ Time Frame: over 6 months ]
- adherence to the study [ Time Frame: 6 months ]
- uptake into the trial (proportion of patients from the longitudinal study participating in the RCT) [ Time Frame: 18 months ]
- change of severity of breathlessness [ Time Frame: baseline and two months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123902
|King's College London|
|London, United Kingdom, SE5 9PJ|
|Principal Investigator:||Claudia Bausewein, PhD MD MSc||King's College London|