WOMENinMOTION An Intervention Model for Pelvic Girdle Pain
NCT ID: NCT07158957
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
592 participants
INTERVENTIONAL
2024-09-19
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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 individually coached content of WIM
motivation for behavioral change
motivation to be physically active
usual maternity health care
usual maternity health care according to regional guidelines including general advice
No interventions assigned to this group
Interventions
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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 individually coached content of WIM
motivation for behavioral change
motivation to be physically active
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* serious intercurrent diseases such as diabetes and high blood pressure.
* multiple pregnancy.
18 Years
FEMALE
Yes
Sponsors
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Göteborg University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Annelie Gutke, PhD, associate professor
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Närhälsan Gibraltargatan rehabmottagning
Gothenburg, , Sweden
Närhälsan Eriksberg rehabmottagning
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-00146
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
VGRINN-979977
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
VGRINN-993309
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Västra Götaland_WIMPGP
Identifier Type: -
Identifier Source: org_study_id
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