Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Miss Flavia Swan
+44 (0)190 446 8335
hyfes@hyms.ac.uk


Study Location:

Castle Hill Hospital
Hull
HU16 5JQ


Skip to Main Content

Calming Hand And Fan Feasibility study

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Breathlessness/palliative medicine


Study summary

Background and study aims
Many people live with continuing distress and difficulties arising from breathlessness despite treatment given to the underlying disease which causes it. Exercise is known to be important and helpful for breathlessness. But, people with breathing difficulties are unwilling to exercise as any exertion triggers the breathlessness. Simple measures may be useful. Two options are the hand held battery operated fan designed to give cool airflow to the face, or the “Calming hand”, a simple breathing strategy that could help reduce anxiety that often occurs with breathlessness. Both are cheap, easy to use and portable providing something that the patient and their carer can use in any circumstances and may form part of a crisis self-management plan. But will such simple interventions provide relief and enable people who are breathless from exercise to recover faster and have more confidence in managing activity in their daily routine. The first stage, therefore, is a initial investigation called to see how we should set up such a study with regard to the following: Will patient participants and carers find the study we propose acceptable and practical? What number of participants and carers would we need to make a subsequent full scale study able to answer our research question and is it possible to recruit sufficient numbers?

Who can participate?
People with refractory breathlessness from any cause and their carer's will be eligible. The study aims to recruit 40 adult, male/female participants from the respiratory and oncology out-patient clinics, Castle Hill hospital, Cottingham, Hull.

What does the study involve?
There will be four different groups and you will be allocated to one of these by a process called "randomisation" like the toss of a coin. You will be given and taught how to use a hand held fan, or the “Calming hand” diagram and procedure, both of these, and/or instructed in the usual breathlessness care. You will be asked to walk up and down a corridor externally paced by an audio signal that gradually increases in pace, using a walking aid if normally required, until you feel your worst or maximal breathlessness tolerance from exercise. When you do not wish to continue walking, you will be instructed to sit down and use either the hand held fan and usual breathlessness care, or the “Calming hand” and usual breathlessness care, both the fan and the “Calming hand” and the usual breathlessness care, or the usual breathlessness care only. You will record your breathlessness scores before exercise, immediately after the exercise at maximal breathlessness and then every minute whilst sitting down during 10 minutes’ recovery. You will be given the Numerical Rating Scale for scoring your breathlessness (a 0 – 10 scale where 0 = no breathlessness, 10 = worst possible breathlessness). You will have the scale explained to you before taking part and you will have help to practise using it.
Information leaflets about the hand held fan, the “Calming hand” or the usual breathlessness care, including guidance about exercise will be available for you to take home afterwards and you will be asked to continue using the treatments(s) and /or usual breathlessness care for the next 28 days, whenever you are feeling breathless from activity or anxiety. The study will last for 28 days and you will be followed up on Day 14 with a telephone call, and then with a second appointment on Day 28 in the Breathlessness Clinic or alternatively a home visit will be offered at your request. You will be asked to score your severity and distress from breathlessness at the start, on Day 14 via the telephone call, and again at the end of the study on Day 28. You will perform the walking test on Day 1 and Day 28 and score your breathlessness in relation to recovery from exercise. You will also be asked to complete some questionnaires at the start and the finish about how you feel you are coping with the breathlessness, and how the symptoms are affecting your quality of life and daily activities. Your carer will also be invited to take part in the study with your permission. If they agree they will be asked to complete some questionnaires at the start on Day 1, and at the end of the study on Day 28 about their quality of life and the strain they may experience in their role as the carer.

What are the possible benefits and risks of participating?
This study is aimed at determining if the use of simple options such as the hand held battery operated fan or the “Calming hand” have any benefit for the symptoms and consequences of breathlessness. There may be potential benefit for the participant and their family. However, this is a initial study and is not designed to specifically provide such benefit. It forms a vital and key stage to the development and design of a subsequent study which will provide benefit to future clinical decision making and care. This is a low risk study, and in previous studies and in clinical practice of over 7 years use in over 600 patients from one clinical centre of one study (Addenbrookes Hospital) there has not been one serious adverse reaction related to the use of the fan. This is in keeping with a device that is in widespread community use, available for unmonitored purchase by the lay population including many elderly people. There are no known risks or harm associated with or without the use of the "Calming hand".

Where is the study run from?
Castle Hill Hospital (UK)

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in December 2012 and that the study will run for approximately 16 months.

Who is funding the study?
Hull York Medical School, Centre for Health and Population Studies (UK)

This is a feasibility study which intends to generate essential information for a larger scale study therefore a study hypothesis is not specified.

1. To test the feasibility of conducting an adequately powered large, multi-centre study comparing the effectiveness of the following treatments at relieving breathlessness from exercise: 1.1. Fan and usual breathlessness care1.2. “Calming hand” and usual breathlessness care1.3. Both, fan and “Calming hand” and usual breathlessness care1.4. Usual breathlessness care only2. To explore the feasibility of the study design in relation to:2.1. Recruitment rates2.2. Acceptability of study protocol to participants and carers2.3. The views of participants and carers with regard to the use of the interventions and the most useful outcomes2.4. The variability of the outcome measures


2x2 factorial un-blinded single-site randomised controlled trial

Key dates

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Dec 2012

01 Dec 2014

Publications

1. 2017 results in https://doi.org/10.1183/1393003.congress-2017.PA749 (added 23/01/2019)

Study type

Interventional

Intervention Type : Other
Intervention Name :
Intervention Description : 1. Fan and usual breathlessness care2. “Calming hand” and usual breathlessness care3. Both, fan and “Calming hand” and usual breathlessness care4. Usual breathlessness care only


Who can take part?

You can take part if:


1. Over 182. Able to provide verbal or written consent to take part in the study3. Living in the community with or without a carer4. Intractable breathlessness from all causes, for whom all reversible components of breathlessness have been addressed5. Level 3 on the Medical Research Council (MRC) Dyspnoea scale6. Have not used the hand held fan or "Calming hand" for breathlessness for 2 weeks7. Willingness to engage with breathlessness training and study measures




You may not be able to take part if:

1. Too breathless to participate in study as assessed by the opinion of investigator and/or patient2. Cognitively impaired and unable to understand the study3. Trigeminal nerve damage/disease


Where can I take part?

Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Castle Hill Hospital
    Hull
    HU16 5JQ

Funders/Sponsors


The study is sponsored by Hull and East Yorkshire (HEY) NHS Trust (UK) and funded by Hull York Medical School, Centre for Health and Population Studies (UK) - PhD Studentship .



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details

for Trial ID: ISRCTN40230190

Last updated

This page is to help you find out about a research study and if you may be able to take part

The information is provided by researchers and we rely on them to keep it up-to-date. You can see more information by clicking on the 'Read full details' link above.

To take part, please print or share the study information with your GP/healthcare provider or contact the research team directly.