Effectiveness of a Hand-held Fan for Breathlessness

May 13, 2010 updated by: King's College London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9PJ
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of severity of breathlessness
Time Frame: between baseline and one month
between baseline and one month

Secondary Outcome Measures

Outcome Measure
Time Frame
use and acceptance of the intervention and the control
Time Frame: over 6 months
over 6 months
adherence to the study
Time Frame: 6 months
6 months
uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)
Time Frame: 18 months
18 months
change of severity of breathlessness
Time Frame: baseline and two months
baseline and two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Claudia Bausewein, PhD MD MSc, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (ESTIMATE)

May 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 05/06-69

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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