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Completed

NCT Number: NCT02944786

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gothenburg

Gothenburg, 40530, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HOPE-model

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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

  1. Change in Minimal Insomnia Symptom Scale (MISS) score

    Time frame: baseline and 5 weeks after baseline

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

  2. Long term Change in Minimal Insomnia Symptom Scale (MISS) score

    Time frame: baseline and 6 months after baseline

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

  3. Change in Numeric Rating Scale (NRS) for school attendance

    Time frame: baseline and 5 weeks after baseline

    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.

  4. Long term in Numeric Rating Scale (NRS) of school attendance

    Time frame: baseline and 6 months after baseline

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

  5. Change of Numeric Rating Scale (NRS) score of pain intensity

    Time frame: baseline and 5 weeks after baseline

    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.

  6. Long term change in Numeric Rating Scale (NRS) score pain intensity

    Time frame: baseline and 6 months after baseline

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

  7. Change in Self-Rated Health (SRH) score

    Time frame: baseline and 5 weeks after baseline

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

  8. Long term change in Self-Rated Health (SRH) score

    Time frame: baseline and 6 months after baseline

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

Other outcomes

  1. Center for Epidemiological Studies Depression Scale for Children (CES-DC) score

    Time frame: Baseline

    A single time point of assessment at baseline

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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