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临床试验/NCT04171336
NCT04171336已完成不适用

Animal-assisted Group Therapy for Children and Adolescents Suffering From Chronic Primary Pain

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3
试验地点
2
主要终点
Pain Severity assessed by Visual Analogue Scale

研究概览

简要总结

Chronic pain is highly prevalent in children and adolescents, up to one in four children will develop pain that persists or recurs for three or more months. Chronic pain is not only linked to significant psychological, physical, and social concerns for affected children and their families, but also places an enormous burden on healthcare systems - in the United States, chronic pain costs around $19.5 billion dollars each year and ranks among the most expensive pediatric health problems. Chronic pain significantly decreases quality of life and is associated with numerous missing days at school or at work.

Several interventions exist, however, for some, the risk-benefit profile is not favorable, or the effect sizes are small and the clinical effect can be questioned. In general, a multidisciplinary approach that includes medical, psychological, and physiological aspects has been shown to be most promising in the treatment of chronic pain in children and adolescents.

Clinical impressions suggest that an Animal-assisted Therapy (AAT) intervention could be promising, but to the best of our knowledge, this is the first study to investigate the effectiveness of an AAT intervention for children and adolescents with chronic pain. With this pragmatic trials investigators aim to investigate the pre- and post-intervention differences in pain levels, levels of emotional distress, and quality of life within participants with chronic pain.

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 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents aged 8-15 years
  • Suffering from chronic pain (i.e., persistent or recurrent pain for 3 or more months, associated with significant emotional distress or functional limitations)
  • Willing to work with therapy animals
  • Fluent in German
  • Willingness to participate

排除标准

  • children younger than 7 years or adolescents older than 16 years of age
  • Acute pain
  • Allergy to animals Aversion against animals

结局指标

主要结局

Pain Severity assessed by Visual Analogue Scale

时间窗: 6 weeks

Self-reported pain severity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain severity.

Pain Defocussing assessed by Visual Analogue Scale

时间窗: 6 weeks

Self-reported pain defocussing scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain defocussing.

Pain Intensity assessed by Visual Analogue Scale

时间窗: 12 weeks

Self-reported pain intensity scored on a 0-10 scale, reported before and after each session. Higher scores indicate higher pain intensity.

Pain Interference assessed by Visual Analogue Scale

时间窗: 6 weeks

Self-reported pain interference scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain interference.

Pain Acceptance assessed by Visual Analogue Scale

时间窗: 6 weeks

Self-reported pain acceptance scored on a 0-10 scale, reported before and after each session. Higher scores indicate more pain acceptance.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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