This study aims to evaluate the effectiveness of a Cloak Shape sham Pediatric Tuina device which can be applied in randomized controlled trials for Pediatric Tuina research.
Chinese pediatric Tuina has been practiced as an option for health promotion, including disease prevention and treatment, more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric Tuina are located on children's fingers, hands and arms, which are unique if it is compared with those for adult tuina. The manipulation is found to be easily accepted by children, as the strength of tuina is gentle and soft. No severe adverse reaction in regards of Chinese pediatric Tuina was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions. However, it is still lack of high quality RCTs (Randomized Controlled Trials) to evaluate its efficacy. The main obstacle is the difficulty to conduct a valid sham Tuina comparison group. In order to solve this problem, the investigators designed a device for sham Tuina, with a Cloak Shaped cover which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes. The whole manipulation process will be invisible under the cover.The investigators aim to detect whether it is effective as a sham device for pediatric Tuina researches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated
The Cloak Shape Device for Genuine Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a genuine Tuina will be manipulated.
Dongguan Kanghua Hospital
Dongguan, Guangdong, China
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations
The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Observers' Evaluations
The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina
We adopt the VRS-4 to indicate diferent confident intensities towards pediatric Tuina from the perspective of parents as follow: not confident, somewhat confident, confident ,very confident.
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina
We adopt the VRS-5 to indicate diferent discomfort intensities towards pediatric Tuina from the perspective of children equal or larger than 3 years old during and after the Tuina as follow: no discomfort; some discomfort; discomfort; very uncomfortable ; uncertain.
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives
We adopt the VRS-4 to indicate diferent trust intensities of the parents towards pediatric Tuina from the perspective of observers' perspectives as follow: Not confident, somewhat confident, confident, very confident.
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Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Compliance of Guardians and Children for Three Continuous PT Therapies
We adopt the VRS-4 to indicate diferent compliance intensities to follow 3 days continuous Tuina therapies as follow:improbable, somewhat improbable, probable, very probable.
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.