Pediatric Functional DyspepsiaNCT07369687
Parent-administered Pediatric Tuina Versus Routine Care for Pediatric Functional Dyspepsia
A study testing parent-administered pediatric tuina in people with Pediatric Functional Dyspepsia, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Pediatric Functional Dyspepsia
- What is being tested?
- parent-administered pediatric tuina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- parent-administered pediatric tuina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-administered pediatric tuinaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: parent-administered pediatric tuina (n=25) | Experimental | Not described Receives: Other: parent-administered pediatric tuina |
| Control group: routine care (n=25) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, and week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start27 Nov 2025
- Primary completion26 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369687
- Sponsor's protocol ID
- PT_PFD_AS
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-administered Pediatric Tuina With Routine Care Versus Routine Care Alone for Pediatric Functional Dyspepsia: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07369687
- Acronym / sponsor ID
- PT_PFD_AS
- Conditions
- Pediatric Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 27 Jan 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: parent-administered pediatric tuina (n=25) | Experimental | Other: parent-administered pediatric tuina |
| Control group: routine care (n=25) | No intervention | – |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| parent-administered pediatric tuinaParents 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. | Other | Intervention group: parent-administered pediatric tuina (n=25) |
Primary outcome
The Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) Chinese version
Time frame: Baseline, week 4, and week 8
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.
5 secondary outcomes
Daily defecation diary Chinese version
Time frame: Baseline, week 4, and week 8
The Children's Eating Behavior Questionnaire (CEBQ) Chinese version
Time frame: Baseline, week 4, and week 8
The Sleep Disturbance Scale for Children (SDSC) Chinese version
Time frame: Baseline, week 4, and week 8
The Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) Chinese version
Time frame: Baseline, week 4, and week 8
The Parenting Stress Index-Short Form (PSI-SF) Chinese version
Time frame: Baseline, week 4, and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-administered pediatric tuina in people with Pediatric Functional Dyspepsia, run by The Hong Kong Polytechnic University 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 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) Chinese version (time frame: Baseline, week 4, and week 8). 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 27 Jan 2026.