The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of a Handheld Fan to Improve Breathlessness - a Feasibility Study to Assess Relief From Breathlessness After Five Minutes Use of a Handheld Fan Directed at the Cheeks|
- Primary outcome measure is time in minutes for which breathlessness is improved after 5 minutes use of the fan directed at the face [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Relief from breathlessness noted on relief score after using the handheld fan [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Correlation between VAS and NRS scales [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: fan directed to cheeks
Blow draft of air generated by fan across cheeks
Device: handheld fan directed to cheeks
Handheld fan directed to cheeks for 5 minutes
Other Name: handheld fan
A previous randomised controlled trial (Galbraith et al, accepted for publication) has shown a reduction in breathlessness after 5 minutes use of a fan directed to the cheeks. This study is a feasibility study to determine how long this beneficial effect lasts.
With the patient in a relaxed sitting position and ensuring there is no other fan or open window blowing air onto the subject, the following will be explained to the patient and then measured and recorded
- Numerical Rating Scale (NRS) for dyspnoea
- Visual analogue scale (VAS) for breathlessness with end anchors
- O2 saturation using pulse oximeter
- Pulse rate using pulse oximeter
- Room temperature and humidity recorded
The patients will be asked to avoid talking or significantly change position throughout the study.
Fan to cheeks The investigator will demonstrate to the patient how to use the handheld fan directed to the cheeks. The appropriate area on the face, which corresponds to the area innervated by 2nd and 3rd trigeminal nerve branches, will be demonstrated by the researcher. The patient will then use the fan as demonstrated and this will be timed for 5 minutes with the patient in a relaxed sitting position.
Assessment following treatment with fan After 5 minutes use of the fan directed at cheeks, the following will be recorded immediately
- NRS and VAS for dyspnoea
- Relief score, a 5 point rating of how much relief from breathlessness the participant has obtained (0=nil, 1= a little relief , 2= moderate relief, 3=good relief, 4=no longer breathless/maximal relief)
- O2 saturation
- Pulse rate
Participants who have had no improvement in breathlessness as measured by VAS, NRS or gained no relief assessed by the relief score will end the study at this point.
Participants who have an improvement in breathlessness will continue the study and NRS and VAS will to be recorded every 10 minutes in alternating order until the NRS or/and VAS have returned to baseline values or reached a steady level.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974558
|Cambridge, Cambs, United Kingdom, Cb2 0QQ|
|Principal Investigator:||Sarah Galbraith, BM||Cambridge UNiversity Hospitals NHS Foundation Trust Addenbrookes Hospital|
|Study Director:||Sara Booth, MD||Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital|