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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey, 34674
        • Uskudar University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
10 munites
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Uskudar University (Other Identifier: Non-Interventional Research Ethics Committee)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings