Chronic Pelvic Pain Among Somali Women Living in Norway: Effect of Self-management Strategies Assessed Through a Single-case Experimental Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain severity in chronic pelvic pain
研究概览
简要总结
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.
详细描述
Single-case experimental design (SCED) with repeated measurements structured into a nonconcurrent 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 the participants 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 are three possible baseline lengths (4, 5, or 6 weeks) and the participants will be randomized to one of the baseline lenghts.
Phase B is the multimodal physiotherapy intervention, which starts immediately after the baseline period (intervention starts in week 5, 6, or 7, depending on the baseline length) and lasts for six months (24 weeks). The intervention consists of two parts. During the first two months (Phase B1), participants receive weekly physiotherapy sessions that include pain education and general physical activity, consisting of exercises targeting strength, mobility, balance, and endurance. During the following four months (Phase B2), participants receive physiotherapy sessions every other week. They continue with pain education and general physical activity, while pelvic floor muscle training and education on pelvic anatomy are introduced during this phase. Participants receive a total of 16 physiotherapy sessions during Phase B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Able to understand simple Norwegian
- •Able to perform physical activity of low to moderate intensity
- •Able to travel to physiotherapy appointments for participation
- •Able and willing to give informed consent to participate.
排除标准
- •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
- •Exercising regularly including pelvic floor muscle training (PFMT) more than once per week.
研究组 & 干预措施
Multimodal physiotherapy
Participants will complete a randomized multiple baseline phase of 4, 5, or 6 weeks before receiving a multimodal physiotherapy intervention.
The intervention includes pain education, general physical activity, and pelvic floor muscle training with guidance and individualized adaptations based on participant needs by a physiotherapist, including a home exercise program performed up to three times per week.
The same core intervention components will be delivered to all participants.
干预措施: Multimodal physiotherapy (Behavioral)
结局指标
主要结局
Pain severity in chronic pelvic pain
时间窗: 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.
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.
Chronic pelvic pain-related distress
时间窗: 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.
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.
Chronic pelvic pain-related interference
时间窗: 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.
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.
次要结局
- Health Literacy(Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Health-related quality of life (EQ-5D-5L descriptive system)(Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Overall health (EQ VAS)(Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Patient-specific functional ability(Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Self-efficacy for managing chronic pelvic pain(Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Perceived change in chronic pelvic pain(Assessed immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Treatment satisfaction(Assessed immediately after completion of Phase B (post-intervention))
- Psychological distress (anxiety and depression symptoms)(Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up)
- Experiences of chronic pelvic pain and the multimodal physiotherapy intervention(Immediately after completion of Phase B (post-intervention), with an optional follow-up interview at 12-months follow-up)
- Physiotherapists' experiences of delivering the multimodal physiotherapy intervention(Immediately after completion of Phase B (post-intervention))