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Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina

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ClinicalTrials.gov Identifier: NCT03474172
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Dongguan Kanghua Hospital
Information provided by (Responsible Party):
Darong Wu, Guangzhou University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Child Device: Cloak Shape Device for Sham Tuina Device: Cloak Shape Device for Real Tuina Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 30, 2020

Arm Intervention/treatment
Experimental: Real Tuina
Participants 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.
Device: 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.

Sham Comparator: Sham Tuina
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.
Device: 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




Primary Outcome Measures :
  1. Accurate rate of the parents evaluation [ Time Frame: When study completes, averagely fifteen minutes after the study begins ]
    The accurate rate of the parents to guess whether their child received a real Tuina or not.


Secondary Outcome Measures :
  1. Accurate rate of the observers evaluation [ Time Frame: When study completes, averagely fifteen minutes after the study begins ]
    The accurate rate of the observers to guess whether the child received a real Tuina or not.

  2. Verbal Rating Scale (VRS) of parent's attitude towards pediatric Tuina [ Time Frame: When study completes, averagely fifteen minutes after the study begins ]
    We adopt the VRS-4 with the higher score representing the more positive attitude to evaluate the degree of the awareness and reliability of the parents towards pediatric Tuina.

  3. VRS of children's perception of pediatric Tuina [ Time Frame: When study completes, averagely fifteen minutes after the study begins ]
    We adopt the VRS-4 with the higher score representing the more positive perception to evaluate the degree of the perception of the children equal or larger than 3 years old during and after the Tuina.

  4. VRS of parent's attitude towards pediatric Tuina from the observers' perspectives [ Time Frame: When study completes, averagely fifteen minutes after the study begins ]
    We adopt the VRS-4 with the higher score representing the more positive attitude to evaluate the degree of the reliability of the parents towards pediatric Tuina from the observers' perspectives.



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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has not been involved in any other clinical trials at the same period of time.
  2. Subject and his/her guardian may coordinate during the clinical trial.
  3. Subject's guardian have signed the informed consent.

Exclusion Criteria:

  1. A history of experiencing Chinese pediatric Tuina on hands,abdomen and back.
  2. A history of convulsion
  3. Subject with the following conditions on the manipulating part: phlebitis,open wound,fracture,tissue damage
  4. Subject has the follow complications: severe dehydration,metabolic acidosis,disorders of consciousness, seizures or twitching, shock, azotemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474172


Contacts
Contact: Lin Dai +86-15817139603 853086865@qq.com

Locations
China, Guangdong
Dongguan Kanghua Hospital Recruiting
Dongguan, Guangdong, China, 523080
Contact: Lingjia Yin, Physician    +8613620056201    632608836@qq.com   
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Dongguan Kanghua Hospital
Investigators
Principal Investigator: Darong Wu, MD,PhD Guangzhou University of Traditional Chinese Medicine

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03474172     History of Changes
Other Study ID Numbers: Z2017-212-01
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Darong Wu, Guangzhou University of Traditional Chinese Medicine:
Pediatric Tuina
Massage therapy
Sham Tuina
Sham massage
Sham device