ChildNCT03474172
Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
A study testing Cloak Shape Device for Genuine Tuina in people with Child, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Child
- What is being tested?
- Cloak Shape Device for Genuine Tuina
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2018to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Child
- Being tested
- Cloak Shape Device for Sham Tuina, Cloak Shape Device for Genuine Tuina
- Keywords
- Pediatric Tuina, Massage therapy, Sham Tuina, Sham massage, Sham device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cloak Shape Device for Sham TuinaDevice
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
Cloak Shape Device for Genuine TuinaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cloak Shape Device for Genuine Tuina |
| 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. Receives: Device: Cloak Shape Device for Sham Tuina |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Secondary outcomes (4)
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.
Measured: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
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.
Measured: 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.
Measured: 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.
Measured: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start2 May 2018
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguan Kanghua Hospital
- Responsible party
- Principal investigator, Darong Wu, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Darong Wu, MD,PhD, Principal investigator, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474172
- Sponsor's protocol ID
- Z2017-212-01
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2018
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
- ClinicalTrials.gov ID
- NCT03474172
- Acronym / sponsor ID
- Z2017-212-01
- Conditions
- Child
- Keywords
- Pediatric Tuina, Massage therapy, Sham Tuina, Sham massage, Sham device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Dongguan Kanghua Hospital
- Study start
- 2 May 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genuine Tuina | Experimental | Device: Cloak Shape Device for Genuine TuinaParticipants 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. |
| Sham Tuina | Sham comparator | Device: Cloak Shape Device for Sham TuinaExcept 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. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cloak Shape Device for Sham TuinaThe 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 | Device | Sham Tuina |
| Cloak Shape Device for Genuine TuinaThe 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. | Device | Genuine Tuina |
Primary outcome
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations
Time frame: 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
Time frame: 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.
4 secondary outcomes
Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina
Time frame: 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
Time frame: 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
Time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darong Wu, MD,PhD principal investigator
Guangzhou University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cloak Shape Device for Genuine Tuina in people with Child, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations (time frame: The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.