Journal of pain and symptom management | 2019
The Hand-Held Fan and the Calming Hand for People With Chronic Breathlessness: A Feasibility Trial.
Abstract
CONTEXT\nThe battery-operated hand-held fan ( fan ) and the Calming Hand (CH), a cognitive strategy, are interventions used in clinical practice to relieve chronic breathlessness.\n\n\nOBJECTIVE\nTo test the feasibility of a Phase III randomized controlled trial (RCT) evaluating the impact of the fan and/or CH compared with exercise advice alone for the relief of chronic breathlessness due to respiratory conditions.\n\n\nMETHODS\nA single-site, feasibility 2 × 2 factorial, nonblinded, mixed-methods RCT was performed. Participants randomly allocated to four groups: fan\xa0+\xa0exercise advice, CH\xa0+\xa0exercise advice, fan\xa0+\xa0CH\xa0+\xa0exercise advice, and exercise advice alone. Measures included recruitment, acceptability, data quality and study outcomes (baseline and day 28), modified Incremental Shuttle Walk Test (mISWT), recovery time from exertion-induced breathlessness, life-space questionnaire, General Self-Efficacy Scale, and breathlessness numerical rating scales. Willing participants and carers were interviewed at study end.\n\n\nRESULTS\nRecruitment/acceptability/data completion: 53 people were screened, 40 randomized and completed (mean age 72\xa0years (SD 9.8), 70% male). There were few missing data (mISWT, n\xa0= 2). Recovery time (seconds) from exertion-induced breathlessness showed most improvement for the fan; mean reduction from baseline -33.5 vs. CH mean increase from baseline 5.7. This represents a recovery speed at day 28 (-20.4%) faster for the fan vs. 4.1% slower for the CH. Qualitative data indicated participants valued the faster recovery and identified the fan as a useful medical device but found the CH unhelpful.\n\n\nCONCLUSION\nA Phase III RCT is feasible. Mixed-methods data synthesis supports recovery time as a novel, meaningful outcome measure.