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Effectiveness of a Hand-held Fan for Breathlessness
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Primary Lung Cancer or Secondary Lung Metastases COPD III/IV | Device: hand-held fan Device: wristband | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial |
- 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 ]
| Enrollment: | 109 |
| Study Start Date: | June 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Device: wristband
Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
- Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
- COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7]
Exclusion Criteria:
- Unable to provide informed consent
- Too ill to be interviewed and not fluent or illiterate in German
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01123902
| United Kingdom | |
| King's College London | |
| London, United Kingdom, SE5 9PJ | |
| Principal Investigator: | Claudia Bausewein, PhD MD MSc | King's College London |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof Irene Higginson, King's College London |
| ClinicalTrials.gov Identifier: | NCT01123902 History of Changes |
| Other Study ID Numbers: |
CREC 05/06-69 |
| Study First Received: | May 11, 2010 |
| Last Updated: | May 13, 2010 |
Keywords provided by King's College London:
|
Breathlessness Dyspnea Hand-held fan Palliative Care |
Additional relevant MeSH terms:
|
Dyspnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on August 21, 2017