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

Samuel Attias^1*Lital Keinan-Boker²Mostafa Somri^1,3Ariel Schiff⁴Gross Yael³Eran Ben-Arye⁵Ibrahim Matter³Gideon Sroka³Gavrieli Sagi³Dan Steinberger³Elad Schiff¹

• ¹Bnai Zion Medical Center, The Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel
• ²University of Haifa, Haifa, Israel
• ³Bnai Zion Medical Center, Haifa, Israel
• ⁴Reichman University, Herzliya, Israel
• ⁵Technion Israel Institute of Technology The Ruth and Bruce Rappaport Faculty of Medicine, Haifa, Israel

Abstract 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 VAS-A (Visual Analogue Scale for Anxiety). 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 two hours 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 to 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.