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

NCT02944786 | Completed

• 1 other identifier: 205205215
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Adolescents; School nurse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in Minimal Insomnia Symptom Scale (MISS) score

  baseline and 5 weeks after baseline

• Long term Change in Minimal Insomnia Symptom Scale (MISS) score

  baseline and 6 months after baseline

• Change in Numeric Rating Scale (NRS) for school attendance

  baseline and 5 weeks after baseline

• Long term in Numeric Rating Scale (NRS) of school attendance

  baseline and 6 months after baseline

• Change of Numeric Rating Scale (NRS) score of pain intensity

  baseline and 5 weeks after baseline

Other Outcomes (1)

• Center for Epidemiological Studies Depression Scale for Children (CES-DC) score

  Baseline

Study Arms (2)

HOPE-model

EXPERIMENTAL

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

Behavioral: HOPE-model

Control

NO INTERVENTION

Standard care

Interventions

HOPE-model BEHAVIORAL

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).

HOPE-model

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All students who fulfill the criteria of chronic pain that is mediated by stress

You may not qualify if:

• Students who cannot speak Swedish or English

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

University of Gothenburg

Gothenburg, 40530, Sweden

Location

Related Publications (7)

• 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.

  PMID: 24533818 RESULT

• 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.

  PMID: 19132311 RESULT

• 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.

  PMID: 18509808 RESULT

• 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.

  PMID: 24699160 RESULT

• 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.

  PMID: 22310560 RESULT

• 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.

  PMID: 23403597 RESULT

• 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.

  PMID: 26399225 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Nilsson, PhD

  Institute of Health and Care Sciences, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)