WOMENinMOTION An Intervention Model for Pelvic Girdle Pain to Acquire Health-promoting Habits in Pregnancy and Prevent Chronic Pain in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 592
- 试验地点
- 2
- 主要终点
- Physical activity: the Pregnancy Physical Activity Questionnaire
研究概览
简要总结
The overall aim is to educate women to handle common pregnancy-related pain experiences to facilitate healthy life-long physical activity habits and prevent chronic pain.
Our developed WOMENinMOTION model with person-centred preventions and interventions focused on management of pain components added to usual care, will be evaluated in a randomized control study against usual care.
Data and method The model WOMENinMOTION is built on pain education and management of the sensory, emotional, and cognitive components of pain. Through pain management and motivation, pregnant women are guided to choose personal tools for health-promoting physical activity and adaptation of daily activities. Instructive films of exercises, pelvic belt application, and knowledge to meet worries are provided digitally. When the digital content is insufficient, the model is supported by physiotherapist.
Plan for project realisation WOMENinMOTION developed in collaboration with women with PGP, will be pilot tested including analysis of focus groups interviews 2024. The model is evaluated by self-reported questionnaires in a multicenter randomised controlled trial 2025-27 with primary outcomes: physical activity, function and health in gestational week 35, 4 months, 1 and 2 years after birth. Secondary outcomes is PGP prevalence, satisfaction with care, and health economy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with or without pelvic girdle pain
排除标准
- •previous fracture, malignancy or surgical interventions (pelvic floor, spine, pelvis, or hip) or disease of musculoskeletal-or nervous system
- •serious intercurrent diseases such as diabetes and high blood pressure.
- •multiple pregnancy.
研究组 & 干预措施
usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))
pregnant women who in addition to usual care get our model WOMENinMOTION (WIM) on a digital platform. When needed, referred to physiotherapy at clinic for WIM
干预措施: knowledge (Other)
usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))
pregnant women who in addition to usual care get our model WOMENinMOTION (WIM) on a digital platform. When needed, referred to physiotherapy at clinic for WIM
干预措施: motivation for behavioral change (Behavioral)
usual maternity health care
usual maternity health care according to regional guidelines including general advice
结局指标
主要结局
Physical activity: the Pregnancy Physical Activity Questionnaire
时间窗: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
different domains of physical activity in every day life
Health by EQ5D
时间窗: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Health-related quality of life by the EuroQol 5-dimension questionnaire.
Function, summary of sensory components of pain
时间窗: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
SENSORY component of pain: Severity and disability of Pelvic Girdle Pain - measured by the Pelvic Girdle Questionnaire (PGQ).
Function, summary of cognitive components of pain
时间窗: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
COGNITIVE component of pain: Self-efficacy for carrying out physical activity - measured by the Pregnancy-Exercise Self-Efficacy Scale (P-ESES).
Function, summary of emotional components of pain
时间窗: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
EMOTIONAL component of pain: Concern about pain - a Numeric Rating Scale of 0-10.
次要结局
- Evening pain(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)
- Pain frequency(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)
- Depressive symptoms(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)
- Person-centered function(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)
- Prevalence of pelvic girdle pain(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)
- Work ability(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)
- health economy(From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth)