Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program

Study 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.

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: HOPE-model


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOPE-model<br>Four person-centred health dialogue sessions that include pain/stress management and education about stress and pain. | Behavioral: HOPE-model<br>* There are 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).<br>|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Efficacy for Daily Activities (SEDA) score | Measurement of changes in SEDA from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline. | baseline and 5 weeks after baseline | 
| Long term change in Self-Efficacy for Daily Activities (SEDA) score | A follow-up measurement of SEDA that will be done at time point 3, i.e. 6 months after baseline. | baseline and 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Minimal Insomnia Symptom Scale (MISS) score | Measurement of changes in MISS from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline. | baseline and 5 weeks after baseline | 
| Long term Change in Minimal Insomnia Symptom Scale (MISS) score | A follow-up measurement of MISS that will be done at time point 3, i.e. 6 months after baseline. | baseline and 6 months after baseline | 
| Change in Numeric Rating Scale (NRS) for school attendance | Measurement of changes in NRS school attendance from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline. | baseline and 5 weeks after baseline | 
| Long term in Numeric Rating Scale (NRS) of school attendance | A follow-up measurement of NRS school attendance that will be done at time point 3, i.e. 6 months after baseline. | baseline and 6 months after baseline | 
| Change of Numeric Rating Scale (NRS) score of pain intensity | Measurement of changes in NRS pain intensity from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline. | baseline and 5 weeks after baseline | 
| Long term change in Numeric Rating Scale (NRS) score pain intensity | A follow-up measurement of NRS pain intensity that will be done at time point 3, i.e. 6 months after baseline. | baseline and 6 months after baseline | 
| Change in Self-Rated Health (SRH) score | Measurement of changes in SRH from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline. | baseline and 5 weeks after baseline | 
| Long term change in Self-Rated Health (SRH) score | A follow-up measurement of SRH that will be done at time point 3, i.e. 6 months after baseline. | baseline and 6 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pain, Adolescents, School nurse