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NCT Number: NCT01123902

Effectiveness of a Hand-held Fan for Breathlessness

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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Key information

Conditions

Primary Lung Cancer or Secondary Lung Metastases COPD III/IV Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King's College London

London, SE5 9PJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hand-held fan

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

Device

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

Primary outcomes

  1. change of severity of breathlessness

    Time frame: between baseline and one month

Secondary outcomes

  1. use and acceptance of the intervention and the control

    Time frame: over 6 months

  2. adherence to the study

    Time frame: 6 months

  3. uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)

    Time frame: 18 months

  4. change of severity of breathlessness

    Time frame: baseline and two months

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 14, 2010
Registry last updated
May 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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