Two interventions to treat pain disorders and post-traumatic symptoms among Syrian refugees: protocol for a randomized controlled trial.
Adult
Humans
Norway
Outcome Assessment, Health Care
Pain Management
/ methods
Pain Measurement
/ methods
Physical Therapy Modalities
Psychotherapy, Group
/ methods
Randomized Controlled Trials as Topic
Refugees
/ psychology
Somatoform Disorders
/ psychology
Stress Disorders, Post-Traumatic
/ physiopathology
Syria
/ ethnology
Chronic pain
Mental health
Physiotherapy
Randomized controlled trial
Refugee
Teaching Recovery Techniques
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
27 Dec 2019
27 Dec 2019
Historique:
received:
12
08
2019
accepted:
18
11
2019
entrez:
29
12
2019
pubmed:
29
12
2019
medline:
20
9
2020
Statut:
epublish
Résumé
There is a high prevalence of pain and post-traumatic symptoms among refugees and feasible interventions to manage these are needed. However, knowledge about the effect of physiotherapy and psychological group interventions among refugees is scarce. Our aim is to determine whether two different interventions, the Physiotherapy Activity and Awareness Intervention (PAAI) and Teaching Recovery Techniques (TRT), reduce pain and post-traumatic symptoms among refugees from Syria living in Norway. Syrian adults with either pain disorders or post-traumatic symptoms, or both, will be recruited to this randomized control trial. The trial will include two separate interventions: participants with dominating pain symptoms will be assigned to the PAAI; and those with a predominance of post-traumatic symptoms will be assigned to the TRT intervention. Participants will be randomized to either the immediate intervention group or the delayed intervention group, for each of the interventions (PAAI and TRT). A minimum of 68 participants will be recruited for the PAAI and 78 participants for TRT, in order to detect clinically and statistically significant symptom improvement, assuming 25-30% attrition after recruitment. The main outcomes for the analyses will be pain intensity measured by the Brief Pain Inventory questionnaire and the scores of the Impact of Events Scale - Revised. The effect will be evaluated at the end of interventions lasting 8 weeks (PAAI) and 6 weeks (TRT) using the same instruments after the end of the intervention, and again 4-6 weeks later. Additionally, a qualitative evaluation will be conducted through an embedded process evaluation and personal interviews with participants after each of the interventions is finished. Our study will determine the feasibility of the implementation of two different interventions and the effect of these interventions among refugees from Syria with pain disorders and/or post-traumatic symptoms. Clinical Trials.gov, NCT03951909. Retrospectively registered on 19 February 2019.
Sections du résumé
BACKGROUND
BACKGROUND
There is a high prevalence of pain and post-traumatic symptoms among refugees and feasible interventions to manage these are needed. However, knowledge about the effect of physiotherapy and psychological group interventions among refugees is scarce. Our aim is to determine whether two different interventions, the Physiotherapy Activity and Awareness Intervention (PAAI) and Teaching Recovery Techniques (TRT), reduce pain and post-traumatic symptoms among refugees from Syria living in Norway.
METHODS/DESIGN
METHODS
Syrian adults with either pain disorders or post-traumatic symptoms, or both, will be recruited to this randomized control trial. The trial will include two separate interventions: participants with dominating pain symptoms will be assigned to the PAAI; and those with a predominance of post-traumatic symptoms will be assigned to the TRT intervention. Participants will be randomized to either the immediate intervention group or the delayed intervention group, for each of the interventions (PAAI and TRT). A minimum of 68 participants will be recruited for the PAAI and 78 participants for TRT, in order to detect clinically and statistically significant symptom improvement, assuming 25-30% attrition after recruitment. The main outcomes for the analyses will be pain intensity measured by the Brief Pain Inventory questionnaire and the scores of the Impact of Events Scale - Revised. The effect will be evaluated at the end of interventions lasting 8 weeks (PAAI) and 6 weeks (TRT) using the same instruments after the end of the intervention, and again 4-6 weeks later. Additionally, a qualitative evaluation will be conducted through an embedded process evaluation and personal interviews with participants after each of the interventions is finished.
DISCUSSION
CONCLUSIONS
Our study will determine the feasibility of the implementation of two different interventions and the effect of these interventions among refugees from Syria with pain disorders and/or post-traumatic symptoms.
TRIAL REGISTRATION
BACKGROUND
Clinical Trials.gov, NCT03951909. Retrospectively registered on 19 February 2019.
Identifiants
pubmed: 31881990
doi: 10.1186/s13063-019-3919-x
pii: 10.1186/s13063-019-3919-x
pmc: PMC6935096
doi:
Banques de données
ClinicalTrials.gov
['NCT03951909']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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