Parent-administered Pediatric Tuina Versus Routine Care for Pediatric Functional Dyspepsia

Parent-administered Pediatric Tuina With Routine Care Versus Routine Care Alone for Pediatric Functional Dyspepsia: a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Functional Dyspepsia
• Intervention / Treatment: Other: parent-administered pediatric tuina

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China, 000000
    • Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria for the children are the following:

  1. age 3-7 years, which represents the optimal period for both pediatric tuina effectiveness and TCM syndrome differentiation for PFD intervention.
  2. documented PFD diagnosis based on ROME IV criteria.

• Inclusion criteria for the parents are the following:

  1. ability to communicate in Cantonese or Mandarin.
  2. willingness to learn and practice intervention techniques
  3. availability to attend training sessions at The Hong Kong Polytechnic University.
  4. signed informed consent.

Exclusion Criteria:

• Exclusion criteria for the children are the following:

  1. current receipt of tuina or massage treatments.
  2. concurrent acute infectious diseases (scarlet fever, chickenpox), hemorrhagic diseases, skin conditions (burns, severe skin lesions, infections), or severe conditions contraindicated for pediatric tuina (fractures, paraplegia).

• Exclusion criteria for the parents are the following:

  1. severe psychiatric disorders (e.g., major depression) or physical conditions hindering intervention delivery.
  2. Montreal Cognitive Assessment (MoCA) score <22 points.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: parent-administered pediatric tuina (n=25)	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.
No Intervention: Control group: routine care (n=25)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, week 4, and week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline, week 4, and week 8

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): April 26, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PT_PFD_AS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No