Abstract
We evaluated the feasibility of a new research methodology designed for conducting a future, large-scale randomized controlled trial (RCT). This future RCT is aimed at evaluating the effects of repeated aromatherapy footbaths on stimulating the onset of labor. Herein, we conducted a pilot RCT with two arms among low-risk pregnant women at or beyond 39 weeks of gestation before labor onset. These two arms consisted of a treatment group performing aromatherapy footbaths twice a day (n = 7) and a usual care group (n = 8). This study was prospectively registered in the Clinical Trials Registry of the University Hospital Medical Information Network in Japan (UMIN000037398). Feasibility was assessed across the domains of acceptability, demand, implementation, practicality, process, resources, and management using questionnaires, researcher records, and semi-structured interviews with the treatment group and midwives at the setting facility. The new research methodology was found to be feasible, although challenges were identified in the process and implementation. For process, the research participation rate was 55.5%. For implementation, the adherence rate among the multiparous participants in the treatment group ranged from 50% to 94%. An imbalance between both groups was found. Areas that need careful planning and methodological improvements include random allocation, treatment method, and participation criteria.