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| Name | Class |
|---|---|
| Dongguan Kanghua Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genuine Tuina | Experimental | 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. |
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| Sham Tuina | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cloak Shape Device for Sham Tuina | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darong Wu, MD,PhD | Guangzhou University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan Kanghua Hospital | Dongguan | Guangdong | 523080 | China |
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All the recuitment work conducted at the outpatient department of pediatrics of Kanghua hospital where is a first class western medical hospital between May.2018 to August.2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real Tuina | Children will receive real 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. Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real 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 real Tuina will be manipulated. |
| FG001 | Sham Tuina | Except for the conventional therapy given by doctors, children 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 by parents and observers. Cloak Shape Device for Sham Tuina: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This study enrolled children as the object to the Tuina therapy. As it is a study to assess the validation of blinding, the outcome assessment will mainly conduct among parents and observers . Questionaire will also be used for children who are over 3 yrs as they can understand. Therefore the units are child-parent-observer
| ID | Title | Description |
|---|---|---|
| BG000 | Real Tuina | Children will receive real 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. Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real 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 real Tuina will be manipulated. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of 60 children |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | parents | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
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The adverse event data were collected during the Tuina therapy and 1 month after the therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Tuina | Children will receive real 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. Cloak Shape Device for Real Tuina: The Cloak Shape Device for Real 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 real Tuina will be manipulated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of department of Clinical Epidemiology | Guangdong Provincial Hospital of Chinese Medicine | +862081887233 | 35842 | darongwu@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2018 | Jul 26, 2019 | Prot_SAP_000.pdf |
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| Cloak Shape Device for Genuine Tuina | Device | 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. |
|
| 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. | 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. | 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. | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
| BG001 | Sham Tuina | Except for the conventional therapy given by doctors, children 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 by parents, observers and children who are equal or older than 3 years old. Cloak Shape Device for Sham Tuina: 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 |
| BG002 | Total | Total of all reporting groups |
| child-parent-observer dyads |
|
| Standard Deviation |
| Month |
| Participants |
|
| Age, Continuous | Age of 60 parents | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Sex information of 60 children | Count of Participants | Participants | No | Participants |
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| Sex: Female, Male | Sex information of 60 parents | Count of Participants | Participants | No | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No | Participants |
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| Education level of parents | Count of Participants | Participants | No | Participants |
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| Occupation of parents | Count of Participants | Participants | No | Participants |
|
| OG001 | Sham Tuina | 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. Cloak Shape Device for Sham Tuina: 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 |
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| Primary | 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. | Posted | Number | observers | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
|
|
|
| Secondary | 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. | Posted | Number | parents | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
|
|
|
| Secondary | 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. | Posted | Number | children | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
|
|
|
| Secondary | 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. | Posted | Number | parents | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
|
|
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| Secondary | 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. | Posted | Number | parents | The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Sham Tuina | Except for the conventional therapy given by doctors, children 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. Cloak Shape Device for Sham Tuina: 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| Observers who were uncertain |
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| Confident |
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| Very confident |
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| Uncertain |
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| Confident |
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| Very confident |
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| Probable |
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| Very probable |
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