- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06290700
Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life
Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life: Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a single blind randomised controlled experimental study. The sample size of the study was calculated using the G*Power 3.1.7 program, considering a 5% margin of error and 95% confidence interval, and was determined to be at least 61. Therefore, the sample was planned to consist of 122 pregnant women, including 61 pregnant women in the intervention group and 61 pregnant women in the control group.
Study Inclusion Criteria Being at least a primary school graduate. Being a primiparous pregnant woman. Being able to provide feedback. Study Exclusion Criteria Being a multiparous pregnant woman. Being a high-risk pregnant woman. Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Manisa, Turkey
- Yonca çiçek okuyan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being at least a primary school graduate.
- Being a primiparous pregnant woman.
- Being able to provide feedback.
Exclusion Criteria:
- Being a multiparous pregnant woman.
- Being a high-risk pregnant woman.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: İntervational group
Neonatal care education given to primiparous pregnant women affect their postpartum maternal function Neonatal care education given to primiparous pregnant women affect their postpartum quality of life?
|
Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained.
The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre.
The data were collected between November 2022 and November 2023.
The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms.
Each pregnant woman was individually enrolled in an education session held in the breastfeeding room.
The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women.
The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.
|
No Intervention: Control group
All pregnant women, those in the control group, were provide with standard
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severity of maternal function by Barkin Index of Maternal Functioning
Time Frame: 10 weeks after after the intervention
|
The scale was used 6 weeks after childbirth
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10 weeks after after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Postpartum Quality of Life Instrument
Time Frame: 10 weeks after after the intervention
|
The scale was used 6 weeks after childbirth
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10 weeks after after the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MCBU_2880
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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