WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

Официальное название

WOMENinMOTION An Intervention Model for Pelvic Girdle Pain to Acquire Health-promoting Habits in Pregnancy and Prevent Chronic Pain in Women

Обзор

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.

Вмешательства

• Другое knowledge
  -knowledge on pain in general and specifically pelvic girdle pain Pregnant women who in addition to usual care get our model WOMENinMOTION on a digital platform with self-directed content areas modules and linked tasks to promote physical activity and function by reducing concerns, pain, and building confidence for physical activity and realistic expectations. When women consider the digital platform insufficient, they are referred to physiotherapy at clinic for physiotherapeutically individual
• Поведенческое motivation for behavioral change
  motivation to be physically active

Первичные конечные точки

• Physical activity: the Pregnancy Physical Activity Questionnaire [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Health by EQ5D [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Function, summary of sensory components of pain [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Function, summary of cognitive components of pain [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Function, summary of emotional components of pain [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]

Вторичные конечные точки (7)

• Person-centered function [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Prevalence of pelvic girdle pain [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Work ability [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Evening pain [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Pain frequency [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• Depressive symptoms [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
• health economy [Срок оценки: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]

Критерии участия

Критерии включения

• pregnant women with or without pelvic girdle pain

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Швеция · 2 центра

• Närhälsan Gibraltargatan rehabmottagning — Gothenburg
• Närhälsan Eriksberg rehabmottagning — Gothenburg

Идентификаторы

NCT: NCT07158957 · Västra Götaland_WIMPGP · 2022-00146 · VGRINN-979977 · VGRINN-993309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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