ConstipationNCT03751267
Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children
A study testing Tuina (massage) in people with Constipation, run by The University of Hong Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Constipation
- What is being tested?
- Tuina (massage)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a. Pre-school age children: Age 2-6 b. Gender: male or female c. Suffered from functional constipation (base on Rome IV criteria) d. Currently receiving rehabilitation service in the pediatric service unit run by Yan Chai Hospital Social Service Department (e.g. Early Education and Training Centre (EETC), Special Child Care Centre (SCCC), On site Pre-school Rehabilitation Service team.) e. The caregiver of the child is committed to participate in the research activities, include:
- bringing the child to attend the treatment sessions and present during the treatment
- observing and recording the constipation related symptom of the child during the study period and respond on the outcome measurement tools.
- (The caregiver is preferred to be a family member, but could also be a child-care provider who live with the study subject.) f. The legal guardian of the study subject, and the caregiver both sign the consent form.
Who cannot join
- Children in the following situation will be excluded from the study:
- who has contra-indication of massage
- who is currently receiving massage as a regular therapy
- who is known to suffer from any physical (anatomical) or physiological (hormonal or other body chemistry) cause that leads to constipation symptoms
Trial locations and contacts
1 site in 1 country.
China1 site
School of Chinese Medicine, The University of Hong Kong
Hong Kong, Hong Kong, 852
About this study
Official title: Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children - a Randomized Control Trial
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
Read more
- if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the constipation and related symptoms experienced by the pre-school age children
- 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.
- 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
- Conditions
- Constipation
- Being tested
- Tuina (massage)
- Keywords
- Paediatric Massage, Constipation, Pre-school Children
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuina (massage)Procedure or surgery
Tuina is massage based on Traditional Chinese Medicine (TCM) principles.
| Study group | Role | What they receive |
|---|---|---|
| Tuina (massage) | Experimental | Tuina is massage based on Traditional Chinese Medicine (TCM) principles. Receives: Procedure: Tuina (massage) |
| Wait-list control | No intervention | This group of patients will receive Tuina (massage) 4 weeks after baseline assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecation frequency per week
Defecation frequency per week
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week
Fecal incontinence frequency per week
Fecal incontinence frequency per week
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week.
Overall treatment success after 4 weeks of treatment
Treatment success was defined as bowel movements ≥ 3 times per week and fecal incontinence ≤ once per 2 weeks.
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week
Secondary outcomes (4)
Frequency of abdominal pain and painful defecation
Abdominal pain and painful defecation based on the bowel diary
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week.
Pictorial scale of pain intensity
The children's subjective level of pain during bowel movement in pictorial scale in a range of 0-10.with 0 as no pain and 10 as extremely painful
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week.
Strengths and Difficulties Questionnaire (SDQ)
SDQ is a brief emotional and behavioural screening questionnaire for children and young people. The tool can capture the perspective of the parents
The 25 items in the SDQ comprise 5 scales of 5 items each. Each item score 0-2. For each of the 5 scales the score can range from 0 to 10 if all items were completed. All subscale except prosocial score added up to total difficulties score
- Emotional symptoms subscale
- Conduct problems subscale
- Hyperactivity/inattention subscale
- Peer relationships problem subscale
- Prosocial behaviour subscale
For parent completed SDQ Total difficulties score Normal 0-13 Borderline 14-16 Abnormal 17-40 Emotional problems score Normal 0-3 Borderline 4 Abnormal 5-10 Conduct problems score Normal 0-2 Borderline 3 Abnormal 4-10 Hyperactivity score Normal 0-5 Borderline 6 Abnormal 7-10 Peer problems score Normal 0-2 Borderline 3 Abnormal 4-10 Prosocial score Normal 6-10 Borderline 5 Abnormal 0-4
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week.
Care-giver's perceived stress level in visual analogue scale
Score of care-giver's perceived stress level based on visual analogue scale in a range of 0-10, with 0 as no stress and 10 as very stressful
Measured: baseline, change from baseline at 4th week; change from baseline at 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start12 Jun 2018
- Primary completion17 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751267
- Sponsor's protocol ID
- UW18-132
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03751267
- Acronym / sponsor ID
- UW18-132
- Conditions
- Constipation
- Keywords
- Paediatric Massage, Constipation, Pre-school Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the constipation and related symptoms experienced by the pre-school age children
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuina (massage) | Experimental | Procedure: Tuina (massage)Tuina is massage based on Traditional Chinese Medicine (TCM) principles. |
| Wait-list control | No intervention | –This group of patients will receive Tuina (massage) 4 weeks after baseline assessments. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- a. Pre-school age children: Age 2-6 b. Gender: male or female c. Suffered from functional constipation (base on Rome IV criteria) d. Currently receiving rehabilitation service in the pediatric service unit run by Yan Chai Hospital Social Service Department (e.g. Early Education and Training Centre (EETC), Special Child Care Centre (SCCC), On site Pre-school Rehabilitation Service team.) e. The caregiver of the child is committed to participate in the research activities, include:
- bringing the child to attend the treatment sessions and present during the treatment
- observing and recording the constipation related symptom of the child during the study period and respond on the outcome measurement tools.
- (The caregiver is preferred to be a family member, but could also be a child-care provider who live with the study subject.) f. The legal guardian of the study subject, and the caregiver both sign the consent form.
Key exclusion criteria (4 listed)
- Children in the following situation will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuina (massage)Tuina is massage based on Traditional Chinese Medicine (TCM) principles. | Procedure or surgery | Tuina (massage) |
Primary outcome
Defecation frequency per week
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week
Defecation frequency per week
Fecal incontinence frequency per week
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
Fecal incontinence frequency per week
Overall treatment success after 4 weeks of treatment
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week
Treatment success was defined as bowel movements ≥ 3 times per week and fecal incontinence ≤ once per 2 weeks.
4 secondary outcomes
Frequency of abdominal pain and painful defecation
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
Pictorial scale of pain intensity
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
Care-giver's perceived stress level in visual analogue scale
Time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuina (massage) in people with Constipation, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defecation frequency per week (time frame: baseline, change from baseline at 4th week; change from baseline at 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.