Does the use of a handheld fan improve intractable breathlessness?
| ISRCTN | ISRCTN44193804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44193804 |
| Secondary identifying numbers | OCRD2005/04 |
- Submission date
- 19/05/2008
- Registration date
- 27/06/2008
- Last edited
- 16/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sara Booth
Scientific
Scientific
Palliative Care, Oncology Centre, Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Randomised controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The use of a handheld fan directed to the cheek does not relieve intractable breathlessness in patients with chronic maximally treated cardiac and respiratory disorders or advanced cancer. |
| Ethics approval(s) | Ethics approval received from the Peterborough and Fenland Local Research Ethics Committee on the 6th September 2005 (ref: 05/Q0106/64). |
| Health condition(s) or problem(s) studied | Breathlessness from malignant or non-malignant cause |
| Intervention | 1. Use of handheld fan directed to the face (active treatment) 2. Use of handheld fan directed to the leg (control arm of study) As per the protocol, the interventions of fan directed to face (active treatment) or to leg (control arm) were for 5 minutes each treatment. Washout periods were 10 minutes. There were no follow ups after the treatment and washout periods were completed as the study comprised a single intervention of treatments carried out in randomised order followed by washout after each treatment. The total carried out over a total duration of less than 1 hour. |
| Intervention type | Other |
| Primary outcome measure | Decrease in visual analogue scale of greater than 10 mm after use of handheld fan directed to face. The primary outcome measure was a recording of visual analogue score for breathlessness. This was measured at baseline (time zero), after 5 minutes use of fan directed to face or leg, at completion of subsequent 10 minute washout period, after 5 minutes use of second treatment ( fan to face or leg) and after final 10 minute washout period. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 13/12/2005 |
| Completion date | 18/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 49 |
| Key inclusion criteria | 1. Patient is chronically breathless 2. Dyspnoea Exertion Scale (DES) levels 2 or above 3. Any diagnosis causing intractable breathlessness 4. Aged greater than 30 years, either sex |
| Key exclusion criteria | 1. Anaemic patients with haemoglobin (Hb) less than 10 g/l 2. Patients with fever greater than 38.0°C in last 24 hours 3. Patients on continuous oxygen 4. Patients requiring short burst oxygen therapy whilst completing the study 5. Patients with diseases or treatment affecting the trigeminal nerve supply 6. Patients on beta blockers 7. Patients with known autonomic neuropathy 8. Patients with peripheral vascular disease 9. Patients with cerebral disease or receiving cerebral radiotherapy 10. Patients with known severe cardiac or intrapulmonary arterio-venous shunts 11. Patients unable to understand or cooperate with study 12. Patients who do not wish to participate in the study 13. Patients whose disease is not maximally medically treated |
| Date of first enrolment | 13/12/2005 |
| Date of final enrolment | 18/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Palliative Care, Oncology Centre, Box 193
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust R&D Department, Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.addenbrookes.org.uk/ |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Other
Investigator initiated and funded (UK) - fans used in the study were donated and investigator time and equipment used was already available within the department
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
