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.