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

NCT07369687 | Active Not Recruiting DMC

• 1 other identifier: PT_PFD_AS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Daily defecation diary Chinese version

  Baseline, week 4, and week 8

• The Children's Eating Behavior Questionnaire (CEBQ) Chinese version

  Baseline, week 4, and week 8

• The Sleep Disturbance Scale for Children (SDSC) Chinese version

  Baseline, week 4, and week 8

• The Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) Chinese version

  Baseline, week 4, and week 8

• The Parenting Stress Index-Short Form (PSI-SF) Chinese version

  Baseline, week 4, and week 8

Study Arms (2)

Intervention group: parent-administered pediatric tuina (n=25)

EXPERIMENTAL

Other: parent-administered pediatric tuina

Control group: routine care (n=25)

NO INTERVENTION

Interventions

parent-administered pediatric tuina OTHER

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.

Intervention group: parent-administered pediatric tuina (n=25)

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 3-7 years, which represents the optimal period for both pediatric tuina effectiveness and TCM syndrome differentiation for PFD intervention.
• documented PFD diagnosis based on ROME IV criteria.
• ability to communicate in Cantonese or Mandarin.
• willingness to learn and practice intervention techniques
• availability to attend training sessions at The Hong Kong Polytechnic University.
• signed informed consent.

You may not qualify if:

• current receipt of tuina or massage treatments.
• 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).
• severe psychiatric disorders (e.g., major depression) or physical conditions hindering intervention delivery.
• Montreal Cognitive Assessment (MoCA) score \<22 points.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, 000000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: November 27, 2025
• Primary Completion: April 26, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)