Back to resultsChinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
Primary Purpose
Diarrhea
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese pediatric massage therapy + usual care
Sham massage therapy + usual care
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring pediatric massage, Tuina therapy, acute diarrhea
Eligibility Criteria
Inclusion Criteria:
- Subject's symptoms meet the diagnosis criteria of acute diarrhea.
- The occurrence of diarrhea is no more than 72 hours.
- Stool frequency is equal or more than 5 times a day.
- Subject has not been involved in any other clinical trials at the same period of time.
- Subject's guardian may coordinate during the clinical trial.
- Subject's guardian have signed the informed consent.
Exclusion Criteria:
- A history of experiencing Chinese pediatric massage on hands
- Subject has cholera or malaria
- Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
- Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia
Sites / Locations
- Dongguan Kanghua Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
pediatric massage
sham massage
Arm Description
Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old.
Patients will receive the same usual care as the experimental group. For the sham massage, 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 childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously.
Outcomes
Primary Outcome Measures
Diarrhea days
The diarrhea times
The baseline and the 1st day of intervention are on the same day.
Secondary Outcome Measures
Global change rating
much better，slightly better，unchanged，slightly worse，much worse
Period of days when the stool character turns to normal
Incidence of Treatment-Emergent Adverse Events
monitor adverse events
Full Information
NCT ID
NCT03005821
First Posted
December 25, 2016
Last Updated
October 25, 2019
Sponsor
Guangzhou University of Traditional Chinese Medicine
Collaborators
Dongguan Kanghua Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03005821
Brief Title
Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
Collaborators
Dongguan Kanghua Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea.
Detailed Description
Chinese pediatric massage has been practised as an option for the treatment of pediatric diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage for health promotion is much longer, it can be traced back to more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is compared with those for adult massage. The manipulation is found to be easily accepted by children, as the strength of massage is gentle and soft. No severe adverse reaction in regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
pediatric massage, Tuina therapy, acute diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pediatric massage
Arm Type
Experimental
Arm Description
Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old.
Arm Title
sham massage
Arm Type
Sham Comparator
Arm Description
Patients will receive the same usual care as the experimental group. For the sham massage, 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 childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously.
Intervention Type
Other
Intervention Name(s)
Chinese pediatric massage therapy + usual care
Intervention Type
Other
Intervention Name(s)
Sham massage therapy + usual care
Primary Outcome Measure Information:
Title
Diarrhea days
Time Frame
Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.
Title
The diarrhea times
Description
The baseline and the 1st day of intervention are on the same day.
Time Frame
On the 3rd day.
Secondary Outcome Measure Information:
Title
Global change rating
Description
much better，slightly better，unchanged，slightly worse，much worse
Time Frame
On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).
Title
Period of days when the stool character turns to normal
Time Frame
Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.
Title
Incidence of Treatment-Emergent Adverse Events
Description
monitor adverse events
Time Frame
Within 14 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject's symptoms meet the diagnosis criteria of acute diarrhea.
The occurrence of diarrhea is no more than 72 hours.
Stool frequency is equal or more than 5 times a day.
Subject has not been involved in any other clinical trials at the same period of time.
Subject's guardian may coordinate during the clinical trial.
Subject's guardian have signed the informed consent.
Exclusion Criteria:
A history of experiencing Chinese pediatric massage on hands
Subject has cholera or malaria
Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia
Facility Information:
Facility Name
Dongguan Kanghua Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523080
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33407547
Citation
Lu T, Yin L, Chen R, Zhang H, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial. Health Qual Life Outcomes. 2021 Jan 6;19(1):4. doi: 10.1186/s12955-020-01636-1.
Results Reference
derived
PubMed Identifier
31815655
Citation
Lu T, Zhang H, Yin L, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial. Trials. 2019 Dec 9;20(1):689. doi: 10.1186/s13063-019-3818-1.
Results Reference
derived
Learn more about this trial
Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
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