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Clinical Trials/NCT02944786
NCT02944786
Completed
Not Applicable

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

Göteborg University1 site in 1 country98 target enrollmentSeptember 2016
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Göteborg University
Enrollment
98
Locations
1
Primary Endpoint
Change in Self-Efficacy for Daily Activities (SEDA) score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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. In the second period of data collection it will be the other way around, i.e., group B will 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 A will be the control group. All participating school nurses and students will once again be interviewed about their experiences of the intervention. The primary outcome in the intervention is self-efficacy and this outcome will be measured before and after the intervention in both group A and group B. Secondary outcomes are self-rated health, quality of sleep, pain intensity, and school attendance and these outcomes will also be measured before and after the intervention in both group A and group B.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
August 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Göteborg University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Students who cannot speak Swedish or English

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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