ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02944786
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Göteborg University

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: HOPE-model Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: HOPE-model
Four person-centred health dialogue sessions that include pain/stress management and education about stress and pain.
Behavioral: HOPE-model
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).

No Intervention: Control
Standard care



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Center for Epidemiological Studies Depression Scale for Children (CES-DC) score [ Time Frame: Baseline ]
    A single time point of assessment at baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944786


Contacts
Contact: Stefan Nilsson, PhD +46738538951 stefan.nilsson.4@gu.se

Locations
Sweden
University of Gothenburg Recruiting
Gothenburg, Sweden, 40530
Contact: Stefan Nilsson, PhD    +46738538951    stefan.nilsson.4@gu.se   
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Stefan Nilsson, PhD Institute of Health and Care Sciences, University of Gothenburg

Publications of Results:

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02944786     History of Changes
Other Study ID Numbers: 205205215
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Göteborg University:
Chronic pain
Adolescents
School nurse

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms