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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
HOPE-model
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Adolescents, School nurse

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Gothenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HOPE-model

Control

Arm Description

Four person-centred health dialogue sessions that include pain/stress management and education about stress and pain.

Standard care

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 17, 2016
Last Updated
February 4, 2020
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02944786
Brief Title
Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program
Acronym
HOPE
Official Title
Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Adolescents, School nurse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOPE-model
Arm Type
Experimental
Arm Description
Four person-centred health dialogue sessions that include pain/stress management and education about stress and pain.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
HOPE-model
Intervention Description
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 Outcome Measure Information:
Title
Change in Self-Efficacy for Daily Activities (SEDA) score
Description
Measurement of changes in SEDA from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Time Frame
baseline and 5 weeks after baseline
Title
Long term change in Self-Efficacy for Daily Activities (SEDA) score
Description
A follow-up measurement of SEDA that will be done at time point 3, i.e. 6 months after baseline.
Time Frame
baseline and 6 months after baseline
Secondary Outcome Measure Information:
Title
Change in Minimal Insomnia Symptom Scale (MISS) score
Description
Measurement of changes in MISS from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Time Frame
baseline and 5 weeks after baseline
Title
Long term Change in Minimal Insomnia Symptom Scale (MISS) score
Description
A follow-up measurement of MISS that will be done at time point 3, i.e. 6 months after baseline.
Time Frame
baseline and 6 months after baseline
Title
Change in Numeric Rating Scale (NRS) for school attendance
Description
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.
Time Frame
baseline and 5 weeks after baseline
Title
Long term in Numeric Rating Scale (NRS) of school attendance
Description
A follow-up measurement of NRS school attendance that will be done at time point 3, i.e. 6 months after baseline.
Time Frame
baseline and 6 months after baseline
Title
Change of Numeric Rating Scale (NRS) score of pain intensity
Description
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.
Time Frame
baseline and 5 weeks after baseline
Title
Long term change in Numeric Rating Scale (NRS) score pain intensity
Description
A follow-up measurement of NRS pain intensity that will be done at time point 3, i.e. 6 months after baseline.
Time Frame
baseline and 6 months after baseline
Title
Change in Self-Rated Health (SRH) score
Description
Measurement of changes in SRH from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Time Frame
baseline and 5 weeks after baseline
Title
Long term change in Self-Rated Health (SRH) score
Description
A follow-up measurement of SRH that will be done at time point 3, i.e. 6 months after baseline.
Time Frame
baseline and 6 months after baseline
Other Pre-specified Outcome Measures:
Title
Center for Epidemiological Studies Depression Scale for Children (CES-DC) score
Description
A single time point of assessment at baseline
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Nilsson, PhD
Organizational Affiliation
Institute of Health and Care Sciences, University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Gothenburg
City
Gothenburg
ZIP/Postal Code
40530
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24533818
Citation
Alfven G, Nilsson S. Validity and reliability of a new short verbal rating scale for stress for use in clinical practice. Acta Paediatr. 2014 Apr;103(4):e173-5. doi: 10.1111/apa.12558. Epub 2014 Feb 18. No abstract available.
Results Reference
result
PubMed Identifier
19132311
Citation
Barkmann C, Erhart M, Schulte-Markwort M; BELLA Study Group. The German version of the Centre for Epidemiological Studies Depression Scale for Children: psychometric evaluation in a population-based survey of 7 to 17 years old children and adolescents--results of the BELLA study. Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:116-24. doi: 10.1007/s00787-008-1013-0.
Results Reference
result
PubMed Identifier
18509808
Citation
Broman JE, Smedje H, Mallon L, Hetta J. The Minimal Insomnia Symptom Scale (MISS): a brief measure of sleeping difficulties. Ups J Med Sci. 2008;113(2):131-42. doi: 10.3109/2000-1967-221.
Results Reference
result
PubMed Identifier
24699160
Citation
Castarlenas E, Sanchez-Rodriguez E, Vega Rde L, Roset R, Miro J. Agreement between verbal and electronic versions of the numerical rating scale (NRS-11) when used to assess pain intensity in adolescents. Clin J Pain. 2015 Mar;31(3):229-34. doi: 10.1097/AJP.0000000000000104.
Results Reference
result
PubMed Identifier
22310560
Citation
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
Results Reference
result
PubMed Identifier
23403597
Citation
Duberg A, Hagberg L, Sunvisson H, Moller M. Influencing self-rated health among adolescent girls with dance intervention: a randomized controlled trial. JAMA Pediatr. 2013 Jan;167(1):27-31. doi: 10.1001/jamapediatrics.2013.421.
Results Reference
result
PubMed Identifier
26399225
Citation
Holm S, Ljungman G, Asenlof P, Linton SJ, Soderlund A. Treating youth in pain: Comparing tailored behavioural medicine treatment provided by physical therapists in primary care with physical exercises. Eur J Pain. 2016 Apr;20(4):626-38. doi: 10.1002/ejp.780. Epub 2015 Sep 24.
Results Reference
result

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

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