Evaluation The Blinding Validation Of Cloak Shape Device For Sham Pediatric Tuina At Children's Clinical Trial

ObjectiveThis study aim to explore a feasible blind method and device which can be applied in clinical study of Pediatric Tuina,meanwhile effectiveness of this method will be evaluated,and a preliminarily analyze for potential factors that may affect the effectiveness of the blind method and device also will be launched,so as to provide reference for further optimizationMethodsWe adopted a randomize double-blind controlled study design,planning to randomly divide 60 patients into real Pediatric Tuina group or sham Pediatric Tuina group(random ratio is 1:1).Both two group used the cloak shape device,the real Pediatric Tuina group applied real Pediatric Tuina operation,while the sham Pediatric Tuina group applied sham Pediatric Tuina operation under the device.After operation,respectively,parents and the third party observers need to choose and record the result that for participants had received what kind of massage method and parents subjective perceptions of Pediatric Tuina.Children older than 3 years old were asked for perception after real or sham Pediatric Tuina.based on these information we determined whether parents and observers can accurately distinguish between real Pediatric Tuina and sham Pediatric Tuina under the blind effect of cloaked shape device,and then assessed the effectiveness and potential influencing factors of this pediatric Tuina blind method covered by cloaked shape device.ResultsA total of 60 children patients were included in the study,including 30 in the real Pediatric Tuina group and 30 in the sham Pediatric Tuina group.All subjects completed the whole process of this experiment.Among all the parents of the subjects,only 28 parents correctly guessed the operation that the child received,that is,the correct guessing rate was 46.67%;No parent thought that operation their children accepted is sham Pediatric Tuina,and only a tiny part of the parents choose to uncertainty,but most parents thought that children was accepted real Tuina operation,so the correct guessing rate for parents on real Pediatric Tuina group is 93.3%,which may have connection with visual effect by fake operation of sham Tuina under the cloak,,or with other factors such as wild guesses,but we can' t excluded some parents saw right through this cloak shape device;The correct guess rate of the observers was 35%,which is somewhat low because 38.3%of the observers chose uncertainty.Among all the children,10 of whom were older than 3 years old,indicated that real Pediatric Tuina or sham Pediatric Tuina that they were received did not make them uncomfortable.There was no statistical difference in the composition of parents' guess between two groups(P>0.05),and there was also no statistical difference in the composition of observers' guess between two groups(P>0.05).There was no statistical difference in the composition of parents' guesses(P>0.05),and no statistical difference in the composition of observers,guesses(P>0.05).There was no significant influence of parents' recognition of Pediatric Tuina,parents' recognition of Pediatric Tuina,education level and other factors on the correct guessing rate(P>0.05).ConclusionIn summary,parents and observers could not accurately judge whether children received was real or sham Tuina when blind method of pedatric Tuina by the cloak shape device was applied,and sham Tuina covered by the cloaked shape device could ensure the effective implementation of blind method in clinical studies requiring the design of blinding.