Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
243 participants
OBSERVATIONAL
2023-04-03
2024-04-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Could read and speak Turkish,
* Between the ages of 18-49.
Exclusion Criteria
* 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.
18 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kocaeli University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sena Dilek Aksoy
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kocaeli University
Kocaeli, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
sdilek12
Identifier Type: -
Identifier Source: org_study_id