Chronic Pain Clinical Trial
— HOPEOfficial title:
Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain
NCT number | NCT02944786 |
Other study ID # | 205205215 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | August 2019 |
Verified date | February 2020 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | University of Gothenburg | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Alfvén 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. — View 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--re — View 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. — View Citation
Castarlenas E, Sánchez-Rodríguez E, Vega Rde L, Roset R, Miró 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/AJ — View 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.0b0 — View Citation
Duberg A, Hagberg L, Sunvisson H, Möller 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. — View Citation
Holm S, Ljungman G, Åsenlöf P, Linton SJ, Söderlund 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.7 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Center for Epidemiological Studies Depression Scale for Children (CES-DC) score | A single time point of assessment at baseline | Baseline | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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