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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-00146 | Other Grant/Funding Number | FORTE | |
| VGRINN-979977 | Other Grant/Funding Number | Västra Götalandsregionens Innovationsfond | |
| VGRINN-993309 | Other Grant/Funding Number | Västra Götalandsregionens Innovationsfond |
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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic)) | Experimental | 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 |
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| usual maternity health care | No Intervention | usual maternity health care according to regional guidelines including general advice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| knowledge | Other | -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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity: the Pregnancy Physical Activity Questionnaire | different domains of physical activity in every day life | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Health by EQ5D | Health-related quality of life by the EuroQol 5-dimension questionnaire. | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Function, summary of sensory components of pain | SENSORY component of pain: Severity and disability of Pelvic Girdle Pain - measured by the Pelvic Girdle Questionnaire (PGQ). | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Function, summary of cognitive components of pain | COGNITIVE component of pain: Self-efficacy for carrying out physical activity - measured by the Pregnancy-Exercise Self-Efficacy Scale (P-ESES). | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Function, summary of emotional components of pain | EMOTIONAL component of pain: Concern about pain - a Numeric Rating Scale of 0-10. | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Person-centered function | Person-centered function, assessed by the Patients Specific Function Scale (PSFS). Two, by the participant, self-chosen activities rated on a numeric rating scale of 0-10; 10 = have full function | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Prevalence of pelvic girdle pain |
| Measure | Description | Time Frame |
|---|---|---|
| Fear avoidance belief | Fear avoidance beliefs questionnaire subscale that measures physical activity (FABQ-PA). Zero is equivalent to no fear avoidance and 24 indicates the highest possible fear avoidance. | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Catastrophizing thoughts |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annelie Gutke, associate professor | Contact | 0766185747 | annelie.gutke@gu.se | |
| Bodil Halvarsson, PhD-student | Contact | +46(0)73-0651911 | bodil.halvarsson@gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Annelie Gutke, PhD, associate professor | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Närhälsan Gibraltargatan rehabmottagning | Recruiting | Gothenburg | 41132 | Sweden |
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| ID | Term |
|---|---|
| D059388 | Pelvic Girdle Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| motivation for behavioral change | Behavioral | motivation to be physically active |
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Prevalence of Pelvic Girdle Pain measured with self-administered pelvic pain provocation tests. |
| From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Work ability | Work ability, measured by one question from the Work Ability Index. | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Evening pain | Evening pain intensity at its worst, measured by a NRS where 10 = worst pain | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Pain frequency | Pain frequency by question | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Depressive symptoms | Symptoms of depression, measured by the Edinburgh Postnatal Depression Scale | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| health economy | Health-economy evaluation with direct/indirect costs (days on sick leave, visits to health care providers). | From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
Using- Pain Catastrophizing Scale, ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 (no catastrophizing thoughts) to 52 (highest possible catastrophizing thoughts) |
| From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth |
| Närhälsan Eriksberg rehabmottagning | Recruiting | Gothenburg | 41764 | Sweden |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D001519 | Behavior |