An interventional study of parent-administered pediatric tuina in Pediatric Functional Dyspepsia, sponsored by The Hong Kong Polytechnic University. Active, not recruiting at 1 site in China. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Title: Parent-administered pediatric tuina with routine care versus routine care alone for pediatric functional dyspepsia: a pilot randomized controlled trial Background: Pediatric functional dyspepsia (PFD) is a common gastrointestinal disorder in children, characterized by chronic or recurrent upper abdominal discomfort without identifiable organic causes. Despite education, dietary, and pharmacological interventions, treatment outcomes remain suboptimal. Traditional Chinese Medicine (TCM) pediatric tuina, a specialized massage therapy specifically for children, has shown promise as a complementary approach, including when administered by parents at home; however, evidence regarding its feasibility and effectiveness is still limited.
Objectives: This study aims to evaluate the feasibility, acceptability, and preliminary effects of parent-administered pediatric tuina (PPT) for children with PFD.
Hypothesis: Children receiving PPT will experience greater improvements in PFD symptoms, eating behavior, sleep quality, and quality of life compared to those receiving routine care (RC) over an 8-week period.
Design and subjects: This is a pilot randomized controlled trial involving 50 parent-child dyads (children aged 3-7 years with PFD) recruited from the community. Participants will be randomized into a PPT group or an RC group at 1:1 ratio.
Interventions: Parents in the PPT group will attend two 2-hour training sessions delivered by a registered TCM practitioner to learn the principles and techniques of pediatric tuina. They will administer pediatric tuina sessions (30 minutes every two days) at home for 8 weeks, tailored to their child's specific TCM diagnosis. The RC group will continue their usual care without additional interventions during the study period.
Main outcome measures: The primary outcome measure is the Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) to assess PFD symptoms. Secondary measures include eating behavior (Children's Eating Behavior Questionnaire), sleep quality (Sleep Disturbance Scale for Children), quality of life (Pediatric Quality of Life Inventory), and parental stress (Parenting Stress Index-Short Form). Outcome assessment will be conducted at baseline, week 4, and week 8. Acceptability, feasibility, satisfaction, adherence, and safety of the intervention will also be assessed.
Data analysis: A linear mixed-effects model will be employed to analyze group-by-time interactions for all outcomes. Adherence and acceptability will be described qualitatively and quantitatively. Statistical significance is set at p \< .05. Thematic analysis will be conducted for qualitative data.
The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Inclusion criteria for the children are the following:
Inclusion criteria for the parents are the following:
Exclusion Criteria:
Exclusion criteria for the children are the following:
Exclusion criteria for the parents are the following:
Other: parent-administered pediatric tuina
Parents in parent-administered pediatric tuina group will attend an online training session (within 2 hours) on pediatric tuina for PFD by Hong Kong registered Chinese medicine practitioners and their children will receive 1st TCM pattern identification with 1st individualized pediatric tuina prescription at Baseline. In Week 4, the participant's children will receive the 2nd TCM pattern identification (the 2nd individualized pediatric tuina prescription and the according manipulation trainings will be provided). Parents are also required to deliver 30-minutes pediatric tuina on their child every other days during the 8 week-study period.
The Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) Chinese version
The Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) is a standardized parent-report measure designed to assess gastrointestinal symptoms in children according to Rome diagnostic criteria. The parent-reported questionnaire evaluates multiple domains including abdominal pain/discomfort, bowel habits, eating patterns, and associated symptoms.
Time frame: Baseline, week 4, and week 8
Daily defecation diary Chinese version
Daily defecation diary will document stool frequency, consistency (Bristol stool form scale), straining, toileting time, and soiling episodes throughout the intervention and follow-up periods.
Time frame: Baseline, week 4, and week 8
The Children's Eating Behavior Questionnaire (CEBQ) Chinese version
The Children's Eating Behavior Questionnaire (CEBQ) is a 35-item parent-report measure questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Time frame: Baseline, week 4, and week 8
The Sleep Disturbance Scale for Children (SDSC) Chinese version
The Sleep Disturbance Scale for Children (SDSC) is a 26-item parent-report questionnaire that evaluates children's sleep problems, assessing children's sleep problems across 6 domains: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhidrosis. Each item is scored on a 5-point Likert scale from 1-5. The higher the total score, the more serious the sleep disturbance is, and a total score of more than 39 is considered to be a sleep disturbance.
Time frame: Baseline, week 4, and week 8
The Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) Chinese version
The Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) is a 23-item parent-report measure of children's health-related quality of life across 4 domains: physical, emotional, social, and school functioning. Parents rate each item on a 5-point scale from 0 (never a problem) to 4 (almost always a problem). Domain scores are computed by transforming items to a 0-100 scale with higher scores indicating better quality of life.
Time frame: Baseline, week 4, and week 8
The Parenting Stress Index-Short Form (PSI-SF) Chinese version
The Parenting Stress Index-Short Form (PSI-SF) is a 36-item self-report measure assessing parental stress levels.
Time frame: Baseline, week 4, and week 8
Plan to share: No
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The Hong Kong Polytechnic University