Randomization, allocation, and blinding
We used blocked randomization with randomly selected block sizes (block size: 3 and 6). This study is an open study; therefore, the name of the group is not blinded. Owing to the nature of the intervention, the participant and evaluator can recognize which intervention has been assigned to the participant. After randomly allocating patients into two groups with a 1 (control group): 2 (intervention group) ratio, baseline assessment will be performed.
Flow chart of the randomized controlled trial