Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Darong Wu
MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician Affiliation: Guangzhou University of Traditional Chinese Medicine
Guangzhou University of Traditional Chinese Medicine