Parent-administered Pediatric Tuina With Routine Care Versus Routine Care Alone for Pediatric Functional Dyspepsia: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) Chinese version
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the children are the following:
- •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.
- •Inclusion criteria for the parents are the following:
- •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.
排除标准
- •Exclusion criteria for the children are the following:
- •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).
- •Exclusion criteria for the parents are the following:
- •severe psychiatric disorders (e.g., major depression) or physical conditions hindering intervention delivery.
- •Montreal Cognitive Assessment (MoCA) score <22 points.
研究组 & 干预措施
Intervention group: parent-administered pediatric tuina (n=25)
干预措施: parent-administered pediatric tuina (Other)
Control group: routine care (n=25)
结局指标
主要结局
The Questionnaire on Pediatric Gastrointestinal Symptoms-Rome IV (QPGS-RIV) Chinese version
时间窗: 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.
次要结局
- 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)