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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: HOPE-model

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
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 40530
    • University of Gothenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard care
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).

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiological Studies Depression Scale for Children (CES-DC) score	A single time point of assessment at baseline	Baseline

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; Chronic pain; School nurse
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 205205215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO