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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03474172

Enrollment

Registered

2018-03-22

Start date

2018-05-02

Completion date

2018-08-15

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child

Keywords

Pediatric Tuina, Massage therapy, Sham Tuina, Sham massage, Sham device

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.

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.

Interventions

DEVICECloak 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

DEVICECloak 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations	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	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.

Secondary

Measure	Time frame	Description
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.	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.
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.	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.
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.	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.
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.	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.

Countries

China

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	30
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.	30
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	30
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	30
Total	120

Baseline characteristics

Characteristic	Real Tuina	Total	Sham Tuina
Age, Continuous	31.20 years STANDARD_DEVIATION 4.473	31.63 years STANDARD_DEVIATION 5.002	32.07 years STANDARD_DEVIATION 5.304
Education level of parents High school or junior college diploma	18 Participants	38 Participants	20 Participants
Education level of parents Less than junior diploma	5 Participants	7 Participants	2 Participants
Education level of parents More than college diploma	7 Participants	15 Participants	8 Participants
Occupation of parents Company stuff	6 Participants	13 Participants	7 Participants
Occupation of parents Housewife	9 Participants	19 Participants	10 Participants
Occupation of parents Individual household or businessman	6 Participants	12 Participants	6 Participants
Occupation of parents Laborer	1 Participants	1 Participants	0 Participants
Occupation of parents Professional person	4 Participants	6 Participants	2 Participants
Occupation of parents Self-employed person	1 Participants	5 Participants	4 Participants
Occupation of parents Service personnel	2 Participants	3 Participants	1 Participants
Occupation of parents Unemployed	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	30 Participants	60 Participants	30 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	21 Participants	23 Participants	10 Participants
Sex: Female, Male Male	17 Participants	14 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 30
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

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.