Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

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
    


Intervention name(s): Tuina (massage)
Intervention type(s): Procedure
Intervention description(s): Tuina is massage based on Traditional Chinese Medicine (TCM) principles.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paediatric Massage, Constipation, Pre-school Children