NCT06745752

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

December 13, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

postpartum periodupper back painlower back painpelvic girdle painincidence

Outcome Measures

Primary Outcomes (3)

  • Evaluation of upper back pain, lower back pain, and pelvic girdle pain

    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

    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

    Filling out the tools used in the research (Information Form and Brief Pain Inventory)

    Postpartum day 56.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back PainLow Back PainPelvic Girdle Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal PainPelvic Pain

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 20, 2024

Study Start

April 3, 2023

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

December 20, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations