The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study

NCT ID: NCT00974558

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-09-30

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.

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

• 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.

Conditions

Dyspnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fan directed to cheeks

Blow draft of air generated by fan across cheeks

Group Type: EXPERIMENTAL

handheld fan directed to cheeks

Intervention Type: DEVICE

Handheld fan directed to cheeks for 5 minutes

Interventions

handheld fan directed to cheeks

Handheld fan directed to cheeks for 5 minutes

Intervention Type: DEVICE

Other Intervention Names

handheld fan

Eligibility Criteria

Inclusion Criteria

• Any patient able and willing to cooperate with the study and who defines themselves as breathless at rest by answering 'yes' to the question, 'Do you currently feel short of breath?'
• Any diagnosis causing breathlessness
• Age >3 0years

Exclusion Criteria

• Patients who have previously used a handheld fan to manage their breathlessness
• Patients with fever >38 0C in last 24 hours
• Patients on continuous oxygen
• Patients requiring short burst oxygen therapy whilst completing the study
• Patients with diseases or treatment affecting the trigeminal nerve supply.
• Patients with other diseases which, in the opinion of the researcher or investigator, may affect the mechanism of action of the fan
• Patients unable to understand or cooperate with study
• Patients who do not wish to participate in the study

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Catherines Hospice

UNKNOWN

Sponsor Role: collaborator

Scarborough acute hospitals Trust

UNKNOWN

Sponsor Role: collaborator

University hospitals Morecambe Bay

UNKNOWN

Sponsor Role: collaborator

St Johns Hospice

UNKNOWN

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Sarah Galbraith

Consultant in palliative medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Galbraith, BM

Role: PRINCIPAL_INVESTIGATOR

Cambridge UNiversity Hospitals NHS Foundation Trust Addenbrookes Hospital

Sara Booth, MD

Role: STUDY_DIRECTOR

Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital

Locations

Addenbrookes Hospital

Cambridge, Cambs, United Kingdom

Countries

United Kingdom

Other Identifiers

A091619

Identifier Type: -

Identifier Source: org_study_id