"Stop the Pain"-A Multicenter, Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 10
- 主要终点
- Change in Pain Symptoms
研究概览
简要总结
This trial aims to compare two training programs for children suffering functional abdominal pain. These two programs are comparable in number of sessions and group sizes, but show differences in content (very focused on pain management vs. more general information and support). Focus of the trial is the evaluation of "Stop the pain", which has shown high effectiveness in one first trial. This time, five clinics, experienced in diagnosis and treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are eligible. The programs imply six weekly group sessions for the children and 2 parent evenings. The study group assumes that participation in "Stop the pain" will reduce pain experience and will improve the children's quality of life and coping strategies - up to 12 months after training.
详细描述
The trial aims to assess the efficacy of a cognitive-behavioral self-management program (intervention group, IG) compared to an equally extensive information-only control group (CG). The interventions contain 6 weekly group sessions and 2 parent meetings according to the cognitive-behavioral, manualized program "Stop the pain with Happy Pingu". Follow up per patient: 3- and 12 months. Children aged 7-12 years suffering functional abdominal pain (according to Rome III criteria H2a, H2b, H2d, H2d1) are eligible. Our primary hypothesis is that for patients in the IG the frequency and intensity of pain will be reduced more successfully and more sustainable than for children in the CG. Secondary hypotheses state that the IG will experience a higher increase in quality of life and psychosocial well-being compared to the active CG.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for medical screening:
- •aged 7-12 years
- •abdominal pain for at least 2 months
- •abdominal pain at least once per week
- •unclear cause for abdominal pain
排除标准
- •for medical screening:
- •very limited German language skills
- •mental retardation
- •adjuvant psychological treatment at point of medical screening
- •participation in a trainingsprogram for abdominal pain in the 6 months prior to medical screening
- •participation in a clinical trial which possibly may have effects on abdominal pain in the 4 weeks prior to medical screening
- •at point of medical screening: therapy or medication for abdominal pain
- •presentation of sibling aged 7-12 years
- •Inclusion Criteria for study participation:
- •pain-predominant functional gastrointestinal disorders according to Rome-III
- •criteria (H2a, H2b, H2d, H2d1)
- •informed consent for study particiaption
- •informed consent for audiotaping of trainings sessions
- •no time constraints for participation in training groups
- •Exclusion Criteria for study participation:
- •psychiatric disorder (internalizing) with primary treatment indication
- •severe externalizing disorder
研究组 & 干预措施
Intervention group
IG participation in the cognitive-behavioral program "Stop the pain with Happy Pingu". The program compromises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (90 min each).
干预措施: Intervention group (Behavioral)
Active control group
CG participation in an information and education control group (physical well-being, health and gastrointestinal tract). The program of the control group compromises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (90 min each).
干预措施: Active control group (Behavioral)
结局指标
主要结局
Change in Pain Symptoms
时间窗: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Primary efficacy endpoint is the frequency and intensity of pain (composite score) over the course of treatment and follow-up (pre, post, 3 and 12 months follow-up). This primary outcome will be assessed by pain diary in children's self-report (over 2 weeks).Statistically, the primary endpoint of the study is defined as the change of the logarithm of the area under the pain-intensity curve over one week from start of treatment to 12 month follow-up. The area under the pain intensity curve (auc) is a measure that reflects pain intensity as well as pain duration and pain frequency and thus can be understood as a composite measure of pain.
次要结局
- Pain-related impairment(up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up)
- Pain-related coping and cognitions(up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up)
- Health-related quality of life(up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up)
研究者
Petra Warschburger
Prof. Dr.
University of Potsdam