Clinical trial · Interventional
Effectiveness of a Hand-held Fan for Breathlessness
Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COPD III/IV | — | UNRESOLVED | — |
| Primary Lung Cancer or Secondary Lung Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hand-held fan | Device | — | UNRESOLVED |
| wristband | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hand-held fan
- interventionNames
- Device: hand-held fan
- type
- PLACEBO_COMPARATOR
- label
- wristband
- interventionNames
- Device: wristband
Primary outcomes (1)
- measure
- change of severity of breathlessness
- timeFrame
- between baseline and one month
Secondary outcomes (4)
- measure
- use and acceptance of the intervention and the control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBausewein C, Booth S, Gysels M, Kuhnbach R, Higginson IJ. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010 Oct 19;9:22. doi: 10.1186/1472-684X-9-22. PMID 20958972