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

NCT03474172 | Completed Results

• 1 other identifier: Z2017-212-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Child

Keywords

Pediatric Tuina; Massage therapy; Sham Tuina; Sham massage; Sham device

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

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.

Device: Cloak Shape Device for Sham Tuina

Interventions

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

Sham Tuina

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.

Genuine Tuina

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Dongguan Kanghua Hospital: collaborator

Study Sites (1)

Dongguan Kanghua Hospital

Dongguan, Guangdong, 523080, China

Location

Results Point of Contact

• Title: Director of department of Clinical Epidemiology
• Organization: Guangdong Provincial Hospital of Chinese Medicine

darongwu@163.com

+862081887233

Study Officials

• Darong Wu, MD,PhD

  Guangzhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician Affiliation: Guangzhou University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 22, 2018
• Study Start: May 2, 2018
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: March 10, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-03

Locations

CN (1)