Late Postpartum Period and Pain

December 17, 2024 updated by: Sena Dilek Aksoy, Kocaeli University

Incidence, Severity, and Determinants of Upper Back, Lower Back, and Pelvic Girdle Pain in the Late Postpartum Period

Upper back, lower back and pelvic girdle pain significantly affect women's lives, especially in the postpartum period. This study aimed to characterize the frequency and severity of upper back, lower back and pelvic girdle pain in the 0 to 2 months postpartum period. The study will be conducted as a cross-sectional and correlational study. Data will be collected using the Information Form and Brief Pain Inventory designed by the researchers. Data will be collected face to face with the participants at the end of the first week, the end of the first month and the end of the second month after birth. IBM SPSS Statistics 29.0 software will be used in the analysis of the data.

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

Research questions

  1. What are the prevalence rates of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum period?
  2. What are the severity rates of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum period?
  3. What are the determinants of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum? The population of the study will consist of postpartum participants registered in a district family health center (FHC) in western Turkey, who meet the inclusion criteria and are willing to participate in the study. The total number of postpartum women registered in the family health center in the year before the study began was 383. Therefore, no sample calculation was made and all participants who gave birth within one year after the beginning of the study will be included in the study.

The data of the study will be collected using the Information Form, and Brief Pain Inventory.

Information Form: This form consists of 15 questions about sociodemographic and obstetric characteristics based on an extensive literature review on the topic.

Brief Pain Inventory: Developed by Cleeland and Ryan in 1994, the Pain Inventory consists of seven items related to pain intensity and the dimension of how pain interferes with daily activities.

Data collection The researcher will explain the purpose of the study to pregnant women who meet the inclusion criteria, invite them to participate, and obtain their consent. Data will be collected from participants at the end of the first postpartum week (when they attend the first postpartum follow-up visit and newborn heel prick test), at the end of the first month (day 28) (when they attend the second dose of neonatal hepatitis B vaccine), and at the end of the second month (week 8 postpartum) (when they attend the first dose of BCG, DTP-Hib-HBV, and IPV vaccines). At the first visit, participants will complete an information form and the Brief Pain Inventory. At the second and third meetings, they will complete only the Brief Pain Inventory.

Statistical analysis Statistical analysis will be performed using IBM SPSS Statistics 29.0 software (IBM Corp., Armonk, NY, USA). Sociodemographic data will be evaluated using descriptive statistical methods (frequency, percentage, mean, standard deviation). Kolmogorov-Smirnov test will be used as normality test. Independent samples analysis, correlation analysis and logistic regression analysis will be used in the analyses. Significance will be accepted as p<0.05.

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.
243

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
      • Kocaeli, Turkey, 41380
        • Kocaeli 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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants who had given birth, aged 18-49, were registered at a district family health center (FHC) in western Turkey, met the inclusion criteria, and volunteered to participate in the study.

Description

Inclusion Criteria:

  • Participants who were 0-2 months postpartum,
  • Could read and speak Turkish,
  • Between the ages of 18-49.

Exclusion Criteria:

  • Participants with past or current mental illness,
  • Those taking antidepressant or anxiolytic medications,
  • Rheumatoid arthritis,
  • Ankylosing spondylitis,
  • Scheuermann disease,
  • Ehlers-danlos syndrome,
  • Spinal surgery,
  • Nerve root compression,
  • Spondylolisthesis,
  • Perineal edema,
  • Hematoma,
  • Wound dehiscence,
  • Bladder catheterization,
  • serious postpartum complications (internal bleeding, femoral artery embolism, pelvic fracture),
  • Those whose babies are in the neonatal intensive care unit,
  • Those who left the research unfinished.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
postpartum women
In the study, the upper back, lower back and pelvic girdle pain status of the participants in the postpartum period will be monitored.

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
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Time Frame: Postpartum day 7.
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Postpartum day 7.
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Time Frame: Postpartum day 28.
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Postpartum day 28.
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Time Frame: Postpartum day 56.
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Postpartum day 56.

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.
Kocaeli 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.
April 3, 2023

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.
April 3, 2024

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.
April 3, 2024

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).
December 13, 2024

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.
December 17, 2024

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.
March 25, 2025

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.
March 25, 2025

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.
December 17, 2024

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.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • sdilek12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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