CPP Among Somali Women in Norway: SCED
ConditionChronic Pelvic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorKristiania University College
About this trial
Chronic pelvic pain (CPP) in women is a condition associated with negative cognitive, behavioral, sexual and emotional consequences. Although multimodal physiotherapy is recommended for women with CPP, it is unclear whether evidence can be adopted to Somali women living in Norway.
This study aims to evaluate a culturally adapted multimodal physiotherapy intervention consisting of pain education, physical activity, pelvic floor muscle training, and self-management strategies among Somali women with CPP.
The study uses a single-case experimental design with a nonconcurrent randomized multiple baseline. The design allows each participant to serve as their own control while all participants receive the intervention. Repeated quantitative outcome measures will evaluate changes in pain-related outcomes, perceived change in condition, treatment satisfaction, quality of life, health literacy, and self-efficacy. Qualitative interviews will explore feasibility and acceptability of the intervention, and the participants' experiences of chronic pelvic pain, and understanding and management of their own health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biological females, aged between 18 and 45 years
Chronic pelvic pain symptoms >3 months
Moderate to severe pain intensity (≥4/10)
Somali background and currently residing in Norway
Disqualifiers
Surgery during the past 12 months and any medical conditions that would interfere with the ability to participate
Severe pathology (malignancy)
Pregnancy, as well as childbirth within the last 12 months and breastfeeding
Severe psychiatric disorders
Trial design
Design model
Single group
Treatments tested in this trial
Multimodal physiotherapy
BehavioralThe intervention consists of a multimodal physiotherapy program including physiotherapist-guided exercises, a home exercise program performed three times per week, and pain education. The intervention is based on a standardized protocol with individualized adaptations according to each participant's symptoms, functional level, and progression. All participants receive the same core intervention components.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Multimodal physiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain severity in chronic pelvic pain
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for severity of pain today. For each scale, 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores indicate greater symptom burden. Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up. The participant can choose to use the Norwegian or the Somali version of the question.
Time frame
Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.2
Chronic pelvic pain-related distress
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for distress of pain today. For each scale, 0 indicates "no distress" and 10 indicates "extreme pain-related distress". Higher scores indicate greater symptom burden. Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up. The participant can choose to use the Norwegian or the Somali version of the question.
Time frame
Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.3
Chronic pelvic pain-related interference
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for interference of pain today. For each scale, 0 indicates "no interference" and 10 indicates "inability to perform activities". Higher scores indicate greater symptom burden. Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up. The participant can choose to use the Norwegian or the Somali version of the question.
Time frame
Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.Secondary outcomes
1
Health Literacy
Assessed using domains 2 (Having sufficient information to manage my health), 3 (Actively managing my health), 4 (Social support for health), and 8 (Ability to find good health information) of the Health Literacy Questionnaire (HLQ), comprising a total of 19 items. Domains 2, 3, and 4 are rated on a 4-point agreement scale, while domain 8 is rated on a 5-point difficulty scale. Each domain is scored and interpreted separately according to the HLQ scoring guidelines. The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Time frame
Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up2
Health-related quality of life (EQ-5D-5L descriptive system)
Health-related quality of life will be assessed using the EQ-5D-5L descriptive system. The questionnaire measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels ranging from no problems to extreme problems/unable to perform the activity. The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Time frame
Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up3
Overall health (EQ VAS)
Overall health will be assessed using the EQ Visual Analogue Scale (EQ VAS) of the EQ-5D-5L. Participants rate their overall health today on a vertical visual analogue scale ranging from 0 (the worst health the participant can imagine) to 100 (the best health the participant can imagine). The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Time frame
Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up4
Patient-specific functional ability
Patient-specific functional ability will be assessed using the Patient-Specific Functional Scale (PSFS). Participants will identify three personally meaningful activities affected by chronic pelvic pain and rate their ability to perform each activity on an 11-point scale from 0 (unable to perform the activity) to 10 (able to perform the activity without difficulty). Higher scores indicate better functional ability. At the initial assessment, a brief interviewer-assisted process will be used to support participants in identifying relevant activities. Subsequent assessments will use the same individually selected activities. The participant can choose to answer in Norwegian or Somali.
Time frame
Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kristiania University College
Lead sponsor
Oslo Metropolitan University
Collaborator
Norwegian Fund for Postgraduate Training in Physiotherapy
Collaborator
Source ClinicalTrials.gov
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