Feasibility Study for a Randomized Controlled Trial of Aromatherapy Footbath for Stimulating Onset of Labor in Term Pregnant Women

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 <i>acceptability</i>, <i>demand</i>, <i>implementation</i>, <i>practicality</i>, <i>process</i>, <i>resources</i>, and <i>management</i> 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 <i>process</i> and <i>implementation</i>. For <i>process</i>, the research participation rate was 55.5%. For <i>implementation</i>, 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.