Effectiveness of a Hand-held Fan for Breathlessness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Lung Cancer or Secondary Lung Metastases COPD III/IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hand-held fan

Group Type EXPERIMENTAL

hand-held fan

Intervention Type DEVICE

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.

wristband

Group Type PLACEBO_COMPARATOR

wristband

Intervention Type DEVICE

Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.

Interventions

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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.

Intervention Type DEVICE

wristband

Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.

Intervention Type DEVICE

Eligibility Criteria

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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.\[7\]