Clinical trial NCT02944786: Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program
Official title: Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Adolescents
School nurse
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 98
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Self-Efficacy for Daily Activities (SEDA) score
timeFrame: baseline and 5 weeks after baseline
measure: Long term change in Self-Efficacy for Daily Activities (SEDA) score
timeFrame: baseline and 6 months after baseline
Secondary outcomes:
measure: Change in Minimal Insomnia Symptom Scale (MISS) score
timeFrame: baseline and 5 weeks after baseline
measure: Long term Change in Minimal Insomnia Symptom Scale (MISS) score
timeFrame: baseline and 6 months after baseline
measure: Change in Numeric Rating Scale (NRS) for school attendance
timeFrame: baseline and 5 weeks after baseline
measure: Long term in Numeric Rating Scale (NRS) of school attendance
timeFrame: baseline and 6 months after baseline
measure: Change of Numeric Rating Scale (NRS) score of pain intensity
timeFrame: baseline and 5 weeks after baseline
measure: Long term change in Numeric Rating Scale (NRS) score pain intensity
timeFrame: baseline and 6 months after baseline
measure: Change in Self-Rated Health (SRH) score
timeFrame: baseline and 5 weeks after baseline
measure: Long term change in Self-Rated Health (SRH) score
timeFrame: baseline and 6 months after baseline
Other outcomes:
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC) score
timeFrame: Baseline
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg
Study officials:
affiliation: Institute of Health and Care Sciences, University of Gothenburg
name: Stefan Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.
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.