NCT04294420已完成不适用
Patient Education in Children and Adolescents With Pain-predominant Functional Gastrointestinal Disorders: a Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Treatment acceptability
研究概览
简要总结
This pilot-study aims to evaluate the effect size and feasibility of patient education for children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria).
详细描述
The patient education will be provided in a group setting and the children will participate along with one of their parents. Education consists of 2-hour long group sessions, given at 2 different occasions within a month.
The hypothesis is that patient education will reduce gastrointestinal symptoms and pain and also improve quality of life in this group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents between 8-17 years (until their 18th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
- •Blood samples, with normal outcome, in terms of complete blood count (CBC), Erythrocyte Sedimentation Rate (ESR), Anti-tissue Transglutaminase Antibody (tTG), and dipstick urinalysis. Faecal Calprotectin should be measured if diarrhea is present.
排除标准
- •Insufficient skills in the Swedish language.
- •Severe psychiatric comorbidity (as suicidality, psychosis etc).
- •Severe somatic comorbidity.
研究组 & 干预措施
Patient education program
Experimental
Patient education program
干预措施: Patient education program (Behavioral)
结局指标
主要结局
Treatment acceptability
时间窗: Baseline to 3 months.
A questionnaire to child /adolescent if they found the education logic. If they believe it will decrease symptoms. If they would recommend it to others
次要结局
- Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)(Baseline to 3 months, baseline to 6 months.)
- Spence Children Anxiety Scale - short version (SCAS-S)(Baseline to 3 months, baseline to 6 months.)
- Children's Somatization Inventory (CSI-24) - subscale for gastrointestinal symptoms (CSI gastro)(Baseline to 3 months, baseline to 6 months.)
- Pediatric Quality of Life Inventory (PedsQL)(Baseline to 3 months, baseline to 6 months.)
- The behavioral responses questionnaire child-adapted short scale (BRQ-C)(Baseline to 3 months, baseline to 6 months.)
- Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)(Baseline to 3 months, baseline to 6 months.)
- Faces Pain Rating Scale. (FACES)(Baseline to 3 months, baseline to 6 months.)
- Child Depression Inventory - short version (CDI-S)(Baseline to 3 months, baseline to 6 months.)
研究者
Agneta Uusijärvi
Principal Investigator
Karolinska Institutet
研究点 (1)
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