- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05976776
Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas
July 2, 2024 updated by: Emine Akca, Amasya University
Effectiveness of a Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas.
A total of 148 pregnant women are planned to be included in the study.
Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory.
The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)).
It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas.
A total of 148 pregnant women are planned to be included in the study.
Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory.
The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)).
Within the scope of the "Childbirth and Parenthood Preparation training" program; Physiological and psychological changes in the mother during pregnancy, daily life during pregnancy, smoking, alcohol and substance use during pregnancy, exercise during pregnancy, nutrition and nutritional support during pregnancy, pregnancy follow-ups, routine examinations and immunization, common problems during pregnancy and suggestions for solutions, signs of danger during pregnancy and what to do, risky pregnancies, drug and human medicinal product management during pregnancy, labor process, drug-free methods for coping with labor pain, postpartum period and its characteristics, physiological changes in the mother after birth, psychological changes in puerperium, puerperal role and adaptation, postpartum behaviors , care of the newborn in the postpartum period, postpartum contraception methods will be explained.
It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
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
-
-
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Amasya, Turkey, 05100
- Amasya University
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-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Literate
- 18-40 years old
- Primigravida
- Those who volunteered to participate in the research
- Pregnant women who do not have communication and mental difficulties
Exclusion Criteria:
- Those who do not fill out the entire questionnaire
- Those with risky pregnancy
- Pregnant women with a previous history of psychiatric illness
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
No intervention
|
|
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Experimental: Experimental group
The Childbirth and Parenthood Preparation Education program
|
The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of 1 month (each week, once a week in total four sessions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Levels of Maternal Health Needs
Time Frame: 1 months
|
Maternal Health Needs is one of the primary outcomes.
This will be measured using 'Maternal Health Needs Scale (MHNS) '.
The minimum score that can be obtained from the scale is "23", the maximum score is "115", and as the scale score increases, maternal health needs also increase.
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy-Related Anxiety Levels
Time Frame: 1 months
|
Pregnancy related anxiety level is another outcomes.
This will be mesured using "Pregnancy-Related Anxiety Scale- Revision 2".
The minimum score that can be obtained from the scale is "11", the maximum score is "55", as the score obtained from the scale increases, the level of anxiety in pregnancy also increases.
|
1 months
|
|
Fetal Health Anxiety Levels
Time Frame: 1 months
|
Fetal Health Anxiety level is another outcomes.
This will be mesured using "Fetal Health Anxiety Inventory (FHAI)".
The minimum score that can be obtained from the scale is "0", the maximum score is "42", as the total score from the scale increases, the level of fetal health anxiety increases.
|
1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emine İbici Akça, Amasya 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)
September 1, 2023
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
July 26, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Amasya Un
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
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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