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

Sponsor
Göteborg University (Other)
Overall Status
Completed
CT.gov ID
NCT02944786
Collaborator
(none)
98
1
2
35
2.8

Study Details

Study Description

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
  • Behavioral: HOPE-model
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
98 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
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Self-Efficacy for Daily Activities (SEDA) score [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]

    A single time point of assessment at baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Gothenburg Gothenburg Sweden 40530

Sponsors and Collaborators

  • Göteborg University

Investigators

  • Principal Investigator: Stefan Nilsson, PhD, Institute of Health and Care Sciences, University of Gothenburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT02944786
Other Study ID Numbers:
  • 205205215
First Posted:
Oct 26, 2016
Last Update Posted:
Feb 6, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Göteborg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2020