Clinical trial NCT03474172: Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
Official title: Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Keywords: Pediatric Tuina
Massage therapy
Sham Tuina
Sham massage
Sham device
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Dongguan Kanghua Hospital
First posted: 2018-03-22
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations
timeFrame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
measure: The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Observers' Evaluations
timeFrame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Secondary outcomes:
measure: Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina
timeFrame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
measure: Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina
timeFrame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
measure: VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives
timeFrame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
measure: Compliance of Guardians and Children for Three Continuous PT Therapies
timeFrame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Kanghua Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou University of Traditional Chinese Medicine
name: Darong Wu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: