Effectiveness of a Hand-held Fan for Breathlessness

This study has been completed.
Sponsor:
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT01123902
First received: May 11, 2010
Last updated: May 13, 2010
Last verified: July 2006

May 11, 2010
May 13, 2010
June 2006
February 2008   (final data collection date for primary outcome measure)
change of severity of breathlessness [ Time Frame: between baseline and one month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01123902 on ClinicalTrials.gov Archive Site
  • use and acceptance of the intervention and the control [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
  • adherence to the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • uptake into the trial (proportion of patients from the longitudinal study participating in the RCT) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • change of severity of breathlessness [ Time Frame: baseline and two months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of a Hand-held Fan for Breathlessness
Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Lung Cancer or Secondary Lung Metastases
  • COPD III/IV
  • 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.
  • Device: wristband
    Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.
  • Experimental: hand-held fan
    Intervention: Device: hand-held fan
  • Placebo Comparator: wristband
    Intervention: Device: wristband
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01123902
CREC 05/06-69
No
Prof Irene Higginson, King's College London
King's College London
Not Provided
Principal Investigator: Claudia Bausewein, PhD MD MSc King's College London
King's College London
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP