- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05418738
The Relationship Between Psychosocial Factors Affecting Pain Perception and Physical Activity Level in Pregnant Women With Lumbopelvic Pain
June 9, 2022 updated by: tuba kolaylı, Uskudar University
Lumbopelvic pain (LPP) is a common condition encountered during pregnancy.
During pregnancy, 50% of women experience LPP.
This study was planned to show the relationship between psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial factors, pregnancy-related distress, catastrophization and pain self-efficacy and physical activity level in pregnant women with lumbopelvic pain.
This study was conducted using the questionnaires.
Study Overview
Status
Completed
Detailed Description
In pregnant women with lumbopelvic pain, physical activity during pregnancy has many positive effects on both maternal and infant health.
Therefore, it is necessary to know the factors affecting physical activity during pregnancy and make arrangements regarding these factors.
This study was planned to reveal the relationship between pregnancy-related psychosocial factors, pregnancy-related distress, catastrophizing, and pain self-efficacy, which affect pain perception, and physical activity level in pregnant women with lumbopelvic pain.
The study was conducted with 60 pregnant women who met the inclusion criteria.
This study was conducted using the questionnaires prepared in the electronic environment and sent to the participants.
This study aims to investigate the relationship between the psychosocial factors affecting pain perception and physical activity levels in pregnant women with LPP.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34674
- Uskudar University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women between the ages of 18-45, who had lumbopelvic pain
Description
Inclusion Criteria:
- Women between the ages of 18-45, who had pain in the lumbopelvic region for more than a week, who had pain between 1-10 according to the VAS, who could read and understand Turkish, who were in the second or third trimester of pregnancy, and who did not exercise regularly before pregnancy were included in this cross-sectional and descriptive study.
Exclusion Criteria:
- having pregnancy complications (preeclampsia, pregnancy-related hypertension, diabetes, etc.), having gynecological or urological problems leading to pain during pregnancy, and having a history of acute or chronic disease, surgical intervention and trauma in the musculoskeletal or nervous system.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Antenatal Psychosocial Health Assessment Scale (ALPHA)
Time Frame: 20 munites
|
ALPHA was used to evaluate the psychosocial states of pregnant women participating in the study.
The ALPHA was created by Yıldız in 2011 to assess the psychosocial health states of pregnant women.
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20 munites
|
|
Tilburg Pregnancy Distress Scale (TPDS)
Time Frame: 10 minutes
|
TPDS, was used to determine the distress states of pregnant women.
The TPDS is used to assess distress developing during pregnancy.
The TPDS, which was created by Pop et al. in 2011, consists of 16 items in total.
|
10 minutes
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: 10 munites
|
PCS, was used to determine ehe level of pain catastrophizing in pregnant women.
It was developed by Sullivan et al. in 1995 to assess the exaggerated and negative mental response of individuals during the pain experience, in other words, their levels of catastrophizing.
The PCS is comprised of 13 items, including the feelings and opinions of individuals about their last pain experience.
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10 munites
|
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The Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 5 munites
|
PSEQ applied to the participating pregnant women was created by M.K. Nicholas in 1989 to assess the confidence of individuals, who experienced pain, in carrying out activities despite pain.
It consists of 10 items.
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5 munites
|
|
The Pregnancy Physical Activity Questionnaire (PPAQ)
Time Frame: 20 minutes
|
PPAQ was used to reveal the physical activity levels of pregnant women.
With this questionnaire, the intensity, frequency, and duration of physical activity are evaluated in pregnant women.
It consists of 32 items that assess housework/caregiving activities, professional activities, sports/exercise activities, transportation activities, and inactivity.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 9, 2022
First Submitted That Met QC Criteria
June 9, 2022
First Posted (Actual)
June 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 14, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Uskudar University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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