Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-06 @ 1:00 PM
Study NCT ID:
NCT03751267
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children - a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research is a collaborative project by HKU and Yan Chai Hospital, funded by Social Welfare Development Fund of HKSAR. The study is designed as a prospective randomized control trial with the primary objective to investigate the efficacy of pediatric tuina (massage) on the functional constipation of pre-school aged children.
Our study is a pragmatic research comparing the pediatrictuina(massage)treatment with care as usual, with the objectives of investigating
1. if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the constipation and related symptoms experienced by the pre-school age children
2. if there is a positive impact on the caregiver-children relationship and the children's behaviour (a sub-group analysis) when the constipation symptoms improved.
The subjects of this study are pre-school age children (age 2-6) who are serviced by Yan Chai Hospital Social Service Department (YCHSS).The subjects will be openly recruited through the service units serving pre-school aged children under YCHSS. Rome IV criteria will be used to identify the children who suffer from constipation.
I. Trial Design This is a multicentre, pragmatic randomized control trial (PRCT) with a prospective design
Hypothesis 1:
Applying regular pediatrictuina (massage) (3 times a week, for 4 weeks ) on pre-school aged children with functional constipation will improve one or more of the following symptoms.
* Frequency of defecations
* Episode of incontinence
* Excessive stool retention
* Painful or hard bowel movements
* Presence of a large fecal mass in the rectum that may obstruct the toilet
Hypothesis 2:
The stress level of the caregiver of the study subjects improve as the constipation syndrome of the subjects improve.
Hypothesis 3:
The children with behavior problem who suffered from constipation will have less behavior issue when their functional constipation syndromes improved
Total 160 pre-school aged children with functional constipation and their caregiver will be openly recruited from the institutions/service units operated by the pediatric service unit of Yan Chai Hospital Social Service Department.The recruited children must suffer from functional constipation symptoms (based on Rome IV criteria). All accepted subjects will be in dyad. (i.e. 1 pre-school aged child and his designated caregiver, who commits bring the child to attend all treatment and assessment sessions, respond to all caregivers' assessment and fill in the daily logbook).
All applications will be screened by the social workers in the centres based on the inclusion and exclusion criteria. Qualified applicants will be invited for a health assessment conducted by registered TCM practitioner in the research team to confirm their suitability and invite them to sign the consent form. The consented dyad will be allocated randomly into treatment group and waitlist control group.
II. Intervention A 10 minutes structured pediatric massage protocol with specific applications technique will be performed on the children allocated to the treatment group three times a week for 4 consecutive weeks by trained TCM practitioners in the service units of YCHSS. The caregivers of the children need to participate in all assessment sessions and fill in the log book provided.
In the 1st 4 weeks, the children in the waitlist control group will not receive any pediatrictuina (massage). After the dyad completed the assessment sessions at baseline and week 4 ,(served as Treatment-as-Usual Control), children in the control group will receive the same 4 weeks of pediatric massage as the treatment group. The data collected before the treatment begins at week 4 will serve as the 2nd baseline for the waitlist control group.
The treatment protocol involve 8 steps.The massage area focuses on the abdomen and lower back of the recipients. All the movements/steps selected are well established and commonly used in the TCM practices. Any movement that demand professional training or involve potential risk is excluded from the protocol.
III. Measurement of efficacy Efficacy of the treatments will be measured in multi dimensions before and after the treatment for both groups. The main outcome measures are defecation frequency per week, fecal incontinence frequency per week, and overall treatment success after 4 weeks intervention, 8 weeks intervention and 12 weeks (4 weeks after intervention stopped) Secondary outcome measures included
* abdominal pain and painful defecation based on bowel diary,
* the children's subjective level of pain during bowel movement,
* score of child behavior questionnaire and
* score of caregiver impact and burden
Our study is a pragmatic research comparing the pediatrictuina(massage)treatment with care as usual, with the objectives of investigating
1. if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the constipation and related symptoms experienced by the pre-school age children
2. if there is a positive impact on the caregiver-children relationship and the children's behaviour (a sub-group analysis) when the constipation symptoms improved.
The subjects of this study are pre-school age children (age 2-6) who are serviced by Yan Chai Hospital Social Service Department (YCHSS).The subjects will be openly recruited through the service units serving pre-school aged children under YCHSS. Rome IV criteria will be used to identify the children who suffer from constipation.
I. Trial Design This is a multicentre, pragmatic randomized control trial (PRCT) with a prospective design
Hypothesis 1:
Applying regular pediatrictuina (massage) (3 times a week, for 4 weeks ) on pre-school aged children with functional constipation will improve one or more of the following symptoms.
* Frequency of defecations
* Episode of incontinence
* Excessive stool retention
* Painful or hard bowel movements
* Presence of a large fecal mass in the rectum that may obstruct the toilet
Hypothesis 2:
The stress level of the caregiver of the study subjects improve as the constipation syndrome of the subjects improve.
Hypothesis 3:
The children with behavior problem who suffered from constipation will have less behavior issue when their functional constipation syndromes improved
Total 160 pre-school aged children with functional constipation and their caregiver will be openly recruited from the institutions/service units operated by the pediatric service unit of Yan Chai Hospital Social Service Department.The recruited children must suffer from functional constipation symptoms (based on Rome IV criteria). All accepted subjects will be in dyad. (i.e. 1 pre-school aged child and his designated caregiver, who commits bring the child to attend all treatment and assessment sessions, respond to all caregivers' assessment and fill in the daily logbook).
All applications will be screened by the social workers in the centres based on the inclusion and exclusion criteria. Qualified applicants will be invited for a health assessment conducted by registered TCM practitioner in the research team to confirm their suitability and invite them to sign the consent form. The consented dyad will be allocated randomly into treatment group and waitlist control group.
II. Intervention A 10 minutes structured pediatric massage protocol with specific applications technique will be performed on the children allocated to the treatment group three times a week for 4 consecutive weeks by trained TCM practitioners in the service units of YCHSS. The caregivers of the children need to participate in all assessment sessions and fill in the log book provided.
In the 1st 4 weeks, the children in the waitlist control group will not receive any pediatrictuina (massage). After the dyad completed the assessment sessions at baseline and week 4 ,(served as Treatment-as-Usual Control), children in the control group will receive the same 4 weeks of pediatric massage as the treatment group. The data collected before the treatment begins at week 4 will serve as the 2nd baseline for the waitlist control group.
The treatment protocol involve 8 steps.The massage area focuses on the abdomen and lower back of the recipients. All the movements/steps selected are well established and commonly used in the TCM practices. Any movement that demand professional training or involve potential risk is excluded from the protocol.
III. Measurement of efficacy Efficacy of the treatments will be measured in multi dimensions before and after the treatment for both groups. The main outcome measures are defecation frequency per week, fecal incontinence frequency per week, and overall treatment success after 4 weeks intervention, 8 weeks intervention and 12 weeks (4 weeks after intervention stopped) Secondary outcome measures included
* abdominal pain and painful defecation based on bowel diary,
* the children's subjective level of pain during bowel movement,
* score of child behavior questionnaire and
* score of caregiver impact and burden
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: