Effectiveness of standard of care, vs. its combination with reflexology and sham reflexology on preoperative anxiety in patients undergoing elective laparoscopic cholecystectomy: a single-blinded randomized controlled trial

Background Preoperative anxiety is common. To date, no randomized controlled trial has examined the effectiveness of reflexology in reducing preoperative anxiety in patients undergoing elective laparoscopic cholecystectomy. Methods A randomized, single blinded, interventional trial was conducted with 300 patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: controls receiving standard-of-care (SoC) only (group 1); intervention group receiving reflexology and SoC (group 2); and a group receiving sham reflexology and SoC (group 3). The primary outcome was the mean difference between the three groups in visual analog scale for anxiety (VAS-A). The secondary outcome was a similar analysis confined to patients experiencing baseline moderate-to-high anxiety. In all groups, level of preoperative anxiety was evaluated at entry and exit from the holding room area (HRA). The evaluation was carried out using the VAS-A questionnaire. The study was registered at clinicaltrials.gov (NCT01733771). Results 101 patients were randomly assigned to the reflexology group, 99 to the sham reflexology arm, and 100 received SoC alone. In all groups, SoC included anxiolytics in 25% of patients received about 2 h before the operation. Baseline anxiety (at entry to HRA) was similar in all groups, averaging 5.3. Between-group analysis comparing the reflexology and sham groups detected 0.8 point difference on 0–10 VAS scale in favor of the reflexology group ( p = 0.022). Subgroup analysis of patients with moderate to high level of anxiety (VAS-A>4) at baseline (consisting of 75% of study participants), indicated 1.3 points difference ( p = 0.023). Conclusions The study findings suggest that reflexology treatments have a small, yet significant advantage over sham reflexology and over standard-of-care in reducing preoperative anxiety, in patients with moderate-to-high levels of anxiety. Clinical trial registration https://clinicaltrials.gov/study/NCT01733771?tab=results , Identifier: NCT01733771.