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临床试验/NCT02944786
NCT02944786已完成不适用

Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain

Göteborg University2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2016年9月1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
98
试验地点
2
主要终点
Change in Self-Efficacy for Daily Activities (SEDA) score

研究概览

简要总结

The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which includes patient education, person-centered health dialogues and pain/stress management), which is an adolescent-centered school health prevention program when adolescents have chronic pain. This is an intervention that has the hypothesis to support students to manage their chronic pain. The primary outcome is self-efficacy. Secondary outcomes are self-rated health, quality of sleep, pain intensity and school attendance. The project aims to evaluate the intervention through qualitative and quantitative data collection by students and school nurses. The project has a hybrid design, which means that outcomes of the intervention and the evaluation of the implementation are taking place in the same data collection. The results of this project can be of great importance in the early detection of students with chronic pain and promote their confidence in their own ability to manage their symptoms.

详细描述

School nurses who perform the person-centered health dialogues with the students will have an education, which includes a various of lectures about person-centered health dialogues, stress/pain management and school nurses (over-)generalizations of gender. The project has a hybrid design, which means that outcomes of the intervention and the evaluation of the implementation are taking place in the same data collection.

All students at the participating schools who fulfill the criteria of chronic pain that is mediated by stress, will be invited to participate in the intervention. The participants will be randomized to either group A or group B.

Participants will once report frequency, duration and intensity of pain and they also fill in the questionnaire Center for Epidemiologic Studies Depression Scale for Children.

In the first period of data collection, the group A will get four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain). Group B will be a control group.

All participating school nurses and students will be interviewed about their experiences of the intervention.

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
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All students who fulfill the criteria of chronic pain that is mediated by stress

排除标准

  • Students who cannot speak Swedish or English

结局指标

主要结局

Change in Self-Efficacy for Daily Activities (SEDA) score

时间窗: baseline and 5 weeks after baseline

Measurement of changes in SEDA from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.

Long term change in Self-Efficacy for Daily Activities (SEDA) score

时间窗: baseline and 6 months after baseline

A follow-up measurement of SEDA that will be done at time point 3, i.e. 6 months after baseline.

次要结局

  • Change of Numeric Rating Scale (NRS) score of pain intensity(baseline and 5 weeks after baseline)
  • Change in Minimal Insomnia Symptom Scale (MISS) score(baseline and 5 weeks after baseline)
  • Change in Numeric Rating Scale (NRS) for school attendance(baseline and 5 weeks after baseline)
  • Long term in Numeric Rating Scale (NRS) of school attendance(baseline and 6 months after baseline)
  • Long term change in Numeric Rating Scale (NRS) score pain intensity(baseline and 6 months after baseline)
  • Change in Self-Rated Health (SRH) score(baseline and 5 weeks after baseline)
  • Long term change in Self-Rated Health (SRH) score(baseline and 6 months after baseline)
  • Long term Change in Minimal Insomnia Symptom Scale (MISS) score(baseline and 6 months after baseline)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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