N/A
Completed N=60
Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
Child
Source: ClinicalTrials.gov NCT03474172 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations — 28; 25; 0; 0 parents
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations |
28; 25; 0; 0; 2; 5 | — |
| PRIMARY The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Observers' Evaluations |
14; 13; 3; 7; 13; 10 | — |
| SECONDARY Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina |
0; 1; 17; 17; 10; 11 | — |
| SECONDARY Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina |
7; 3; 0; 0; 0; 0 | — |
| SECONDARY VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives |
0; 0; 15; 18; 12; 9 | — |
| SECONDARY Compliance of Guardians and Children for Three Continuous PT Therapies |
0; 0; 1; 1; 25; 26 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03474172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.