Hasha Wegdan, Fadnes Lars T, Igland Jannicke, Vårdal Rolf, Giusti Line Merete, Strømme Elisabeth Marie, Haj-Younes Jasmin, Heltne Unni, Kumar Bernadette N, Diaz Esperanza
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.
Trials. 2019 Dec 27;20(1):784. doi: 10.1186/s13063-019-3919-x.
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: 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.
难民中疼痛和创伤后症状的患病率很高，因此需要可行的干预措施来应对这些问题。然而，关于难民中物理治疗和心理团体干预效果的知识却很匮乏。我们的目的是确定两种不同的干预措施，即物理治疗活动与认知干预（PAAI）和创伤恢复技术教学（TRT），是否能减轻居住在挪威的叙利亚难民的疼痛和创伤后症状。
方法/设计：患有疼痛障碍或创伤后症状，或两者皆有的叙利亚成年人将被招募到这项随机对照试验中。该试验将包括两种独立的干预措施：以疼痛症状为主的参与者将被分配到PAAI；以创伤后症状为主的参与者将被分配到TRT干预。对于每种干预措施（PAAI和TRT），参与者将被随机分配到立即干预组或延迟干预组。为了在招募后假设25%-30%的损耗率的情况下检测出具有临床和统计学意义的症状改善，PAAI至少将招募68名参与者，TRT至少将招募78名参与者。分析的主要结果将是通过简明疼痛量表问卷测量的疼痛强度和事件影响量表修订版的得分。在持续8周（PAAI）和6周（TRT）的干预结束时，使用相同的工具在干预结束后以及4-6周后再次评估效果。此外，在每种干预措施结束后，将通过嵌入式过程评估和对参与者的个人访谈进行定性评估。
我们的研究将确定实施两种不同干预措施的可行性以及这些干预措施对患有疼痛障碍和/或创伤后症状的叙利亚难民的效果。
ClinicalTrials.gov，NCT03951909。于2019年2月19日进行回顾性注册。
