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WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07158957
Acronym
WIMPGP
Enrollment
592
Registered
2025-09-08
Start date
2024-09-19
Completion date
2027-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Girdle Pain, Physical Activity

Keywords

pregnancy-related pelvic girdle pain, prevention of chronic pain, health-promotion, pain education, digital intervention,

Brief summary

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.

Interventions

OTHERknowledge

-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

BEHAVIORALmotivation for behavioral change

motivation to be physically active

Sponsors

Göteborg University
CollaboratorOTHER
Vastra Gotaland Region
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* pregnant women with or without pelvic girdle pain

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Function, summary of cognitive components of painFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthCOGNITIVE 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 painFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthEMOTIONAL component of pain: Concern about pain - a Numeric Rating Scale of 0-10.
Physical activity: the Pregnancy Physical Activity QuestionnaireFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthdifferent domains of physical activity in every day life
Health by EQ5DFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthHealth-related quality of life by the EuroQol 5-dimension questionnaire.
Function, summary of sensory components of painFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthSENSORY component of pain: Severity and disability of Pelvic Girdle Pain - measured by the Pelvic Girdle Questionnaire (PGQ).

Secondary

MeasureTime frameDescription
Pain frequencyFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthPain frequency by question
health economyFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthHealth-economy evaluation with direct/indirect costs (days on sick leave, visits to health care providers).
Depressive symptomsFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthSymptoms of depression, measured by the Edinburgh Postnatal Depression Scale
Person-centered functionFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthPerson-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
Prevalence of pelvic girdle painFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthPrevalence of Pelvic Girdle Pain measured with self-administered pelvic pain provocation tests.
Work abilityFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthWork ability, measured by one question from the Work Ability Index.
Evening painFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthEvening pain intensity at its worst, measured by a NRS where 10 = worst pain

Other

MeasureTime frameDescription
Fear avoidance beliefFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthFear 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.
Catastrophizing thoughtsFrom enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthUsing- 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)

Countries

Sweden

Contacts

Primary ContactAnnelie Gutke, associate professor
annelie.gutke@gu.se0766185747
Backup ContactBodil Halvarsson, PhD-student
bodil.halvarsson@gu.se+46(0)73-0651911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026