BackgroundBurn-specific pain anxiety and sleep disorders are common factors in burned patients that affect wound healing process, as well as the severity of burn pain. This study aimed to investigate the effect of foot reflexology massage on burn-specific pain anxiety and sleep condition of patients hospitalized in the burn ICU. MethodIn this randomized controlled clinical trial, 52 patients were assigned by permuted block randomization 1:1 to the intervention (n=26) and control (n=26) groups. The intervention group received 20min of foot reflexology massage during 3 days on their third, fourth and fifth days of hospitalization and 15min before changing wound dressings. Patients in the control group merely received routine care. The Burn-Specific Pain Anxiety Scale (BSPAS) was completed for three consecutive days before and after changing wound dressings, and St. Mary's Hospital Sleep Questionnaire (SMHSQ) was filled out for four consecutive days before changing wound dressings for patients in both groups. The data were analyzed by IBM SPSS 16 software, Chicago, independent t, Chi-square, Friedman, Mann–Whitney and Wilcoxon tests. FindingsWe found no significant difference between pain-anxiety in the two groups before the intervention. The trend of different days in each groups were compared with Friedman test and showed that pain anxiety (p<0.001), sleep latency (p<0.001), duration of the last day's sleep (p<0.001) and satisfaction of the last night sleep (p<0.001) had a significant difference. In addition, Mann–Whitney test results showed that there were significant differences between the two groups at different times in terms of the above variables (p<0.05). The effect size was=0.82 for pain anxiety between group after the intervention. ConclusionBased on the results, foot reflexology massage can effectively reduce pain anxiety levels and improve sleep quality and quantity of patients with burn injuries; therefore, this non- pharmacological therapeutic method is recommended to be used in the burn ICUs. (Clinical trial’s registration code: IRCT20110906007494N27)