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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474172
• Other study ID #: Z2017-212-01
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: March 2020
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

1. Children with disease in Pediatric Outpatient Department of Kanghua Hospital

2. Children aged 0-6 years.

3. Guardian and child can be cooperative over the study period.

4. Guardian signed the informed consent.

5. Children have no attendance in other studies simultaneously.

Exclusion Criteria:

1. Child with one or more PT experiences on arms, abdomen or back.

2. Child with a previous history of convulsion.

3. Child with any of the following conditions on the area to be manipulated: phlebitis, open wound, fracture and tissue damage.

4. Child combined with any of following conditions: disorders of consciousness, seizures or twitching, shock, varicella, hand-foot-mouth disease, encephalitis B, and etc.

Related Conditions & MeSH terms

• Child

Intervention

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
• Cloak Shape Device for Genuine Tuina
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.

Locations

Country	Name	City	State
China	Dongguan Kanghua Hospital	Dongguan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Dongguan Kanghua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
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.	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.	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.	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.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
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.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.