The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study
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| First Received Date ICMJE | September 9, 2009 | ||||||||
| Last Updated Date | June 22, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00974558 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | The aim of the study is to investigate if the use of a handheld fan directed to the cheeks alongside conventional medical treatment partially or totally relieves breathlessness and if this effect lasts for at least 30 minutes in patients irrespective of the underlying disease process. |
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| Detailed Description | 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
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
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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dyspnea | ||||||||
| Intervention ICMJE | Device: handheld fan directed to cheeks
Handheld fan directed to cheeks for 5 minutes
Other Name: handheld fan |
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| Study Arm (s) | Experimental: fan directed to cheeks
Intervention: Device: handheld fan directed to cheeks |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 31 | ||||||||
| Estimated Completion Date | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00974558 | ||||||||
| Other Study ID Numbers ICMJE | A091619 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr Sarah Galbraith, Addenbrookes Hospital | ||||||||
| Study Sponsor ICMJE | Cambridge University Hospitals NHS Foundation Trust | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Cambridge University Hospitals NHS Foundation Trust | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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