CPP Among Somali Women in Norway: SCED

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Single‐case experimental design (SCED) with repeated measurements structured into anonconcurrent randomized multiple baseline design is the method of this study.The study is divided into pre‐intervention, baseline (Phase A), the intervention period(Phase B), post‐intervention and follow‐up.Pre‐intervention is the time period before baseline (Phase A). During this timperiod theparticipants will fill out the first questionnaire package.Phase A is the baseline phase before initiation of the intervention. During this phase,pain‐related outcomes and overall health (EQ VAS) will be measured repeatedly. There arethree possible baseline lengths (4, 5, or 6 weeks) and the participants will berandomized to one of the baseline lenghts.Phase B is the multimodal physiotherapy intervention, which starts immediately after thebaseline period (intervention starts in week 5, 6, or 7, depending on the baselinelength) and lasts for six months (24 weeks). The intervention consists of two parts.During the first two months (Phase B1), participants receive weekly physiotherapysessions that include pain education and general physical activity, consisting ofexercises targeting strength, mobility, balance, and endurance. During the following fourmonths (Phase B2), participants receive physiotherapy sessions every other week. Theycontinue with pain education and general physical activity, while pelvic floor muscletraining and education on pelvic anatomy are introduced during this phase. Participantsreceive a total of 16 physiotherapy sessions during Phase B.Throughout the intervention period (Phase B), participants will be encouraged to performhome‐based exercises weekly as part of a self‐management approach, supported by trainingdiaries and individualized follow‐up from women's health physiotherapists.Post‐intervention is the time period six months after baseline (Phase A) and immediatelyafter intervention (Phase B). During this timperiod the participants will fill out thesecond questionnaire package and participate in individual interviews. Thephysiotherapists delivering the intervention will also participate in individualinterviews.Follow‐up assessments will be conducted 12 months after baseline (Phase A). At thistimperiod the participants will fill out the last questionnaire package and a secondoptional individual interview.Outcomes are measured repeatedly within the baseline and intervention phases, allowingeach participant to serve as their own control and enabling evaluation of changesfollowing intervention initiation.Pre‐intervention, post‐intervention, and follow‐up questionnaire assessments will includeoutcomes related to health literacy, quality of life, function, self‐efficacy, perceivedchange in condition, treatment satisfaction, and mental health symptoms.
Epistemonikos ID: b4c0882c2be588f71f3403ebd1da539eaf8c3dd8
First added on: Sep 16, 2026