Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina

Not Applicable

Completed

Conditions: Child

Interventions: Device: Cloak Shape Device for Sham Tuina
Device: Cloak Shape Device for Genuine Tuina

Registration Number: NCT03474172

Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Children with disease in Pediatric Outpatient Department of Kanghua Hospital
Children aged 0-6 years.
Guardian and child can be cooperative over the study period.
Guardian signed the informed consent.
Children have no attendance in other studies simultaneously.

Exclusion Criteria

Child with one or more PT experiences on arms, abdomen or back.
Child with a previous history of convulsion.
Child with any of the following conditions on the area to be manipulated: phlebitis, open wound, fracture and tissue damage.
Child combined with any of following conditions: disorders of consciousness, seizures or twitching, shock, varicella, hand-foot-mouth disease, encephalitis B, and etc.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Tuina	Cloak Shape Device for Sham Tuina	Except for the conventional therapy given by doctors, participants in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed.
Genuine Tuina	Cloak Shape Device for Genuine Tuina	Participants will receive genuine tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.

Primary Outcome Measures

Name	Time	Method
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.	The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Observers' Evaluations	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.	The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.

Secondary Outcome Measures

Name	Time	Method
Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.	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.
VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.	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.
Compliance of Guardians and Children for Three Continuous PT Therapies	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.	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.
Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.	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.