Context: The battery-operated hand-held fan (“fan”)and the Calming Hand (CH), a cognitive strategy, are interventions used in clinical practice to relieve chronic breathlessness. Objective: To 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. Methods: A single-site, feasibility “2 × 2” factorial, nonblinded, mixed-methods RCT was performed. Participants randomly allocated to four groups: fan + exercise advice, CH + exercise advice, fan + CH + exercise 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. Results: Recruitment/acceptability/data completion: 53 people were screened, 40 randomized and completed (mean age 72 years (SD 9.8), 70% male). There were few missing data (mISWT, n = 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. Conclusion: A Phase III RCT is feasible. Mixed-methods data synthesis supports recovery time as a novel, meaningful outcome measure.
Swan, F., English, A., Allgar, V., Hart, S. P., & Johnson, M. J. (2019). The hand-held fan and the Calming Hand for people with chronic breathlessness: a feasibility trial. Journal of pain and symptom management, 57(6), 1051-1061.e1. https://doi.org/10.1016/j.jpainsymman.2019.02.017