Calming Hand And Fan Feasibility study

Effectiveness of the "Calming Hand" and the hand held fan for the relief of refractory breathlessness from exercise in palliative patients and the self-efficacy of the interventions in a "ritual for crisis" plan for the patient and carer: a feasibility study using a 2x2 factorial randomised controlled trial design

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40230190

Enrollment

Registered

2012-10-30

Start date

2012-12-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathlessness/palliative medicine Signs and Symptoms Shortness of breath

Interventions

1. Fan and usual breathlessness care 2. ?Calming hand? and usual breathlessness care 3. Both, fan and ?Calming hand? and usual breathlessness care 4. Us

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Over 18 2. Able to provide verbal or written consent to take part in the study 3. Living in the community with or without a carer 4. Intractable breathlessness from all causes, for whom all reversible components of breathlessness have been addressed 5. Level 3 on the Medical Research Council (MRC) Dyspnoea scale 6. Have not used the hand held fan or "Calming hand" for breathlessness for 2 weeks 7. Willingness to engage with breathlessness training and study measures

Exclusion criteria

Exclusion criteria: 1. Too breathless to participate in study as assessed by the opinion of investigator and/or patient 2. Cognitively impaired and unable to understand the study 3. Trigeminal nerve damage/disease

Design outcomes

Primary

Measure	Time frame
This is a pilot study that aims to establish feasibility, therefore the primary outcome is not specified or decided. The objective will be to assess the variability of the outcome measures (breathlessness intensity, distress and unpleasantness; activity; recovery time from breathlessness; self ?management; carer burden) to inform the choice of a primary end-point and to enable a sample size calculation for a subsequent larger future study. At this stage the proposed primary outcome measure will be the Numerical Rating Scale (NRS) of breathlessness intensity.	—

Measure

Time frame

This is a pilot study that aims to establish feasibility, therefore the primary outcome is not specified or decided. The objective will be to assess the variability of the outcome measures (breathlessness intensity, distress and unpleasantness; activity; recovery time from breathlessness; self ?management; carer burden) to inform the choice of a primary end-point and to enable a sample size calculation for a subsequent larger future study. At this stage the proposed primary outcome measure will be the Numerical Rating Scale (NRS) of breathlessness intensity.

—

Secondary

Measure	Time frame
This is a feasibility study therefore, the secondary outcome measures are also not specified or decided. The objective will be to assess the variability of these outcome measures to inform the choice for a larger future study.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026