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Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas

Primary Purpose

Pregnancy Related, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Childbirth and Parenthood Preparation Education
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy Related focused on measuring Maternal Health Needs, Fetal Health Anxiety, Primiparous women, Childbirth and Parenthood Preparation Education, Pregnancy-Related Anxiety

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Amasya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

The Childbirth and Parenthood Preparation Education program

No intervention

Outcomes

Primary Outcome Measures

Levels of Maternal Health Needs
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.

Secondary Outcome Measures

Pregnancy-Related Anxiety Levels
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.
Fetal Health Anxiety Levels
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.

Full Information

First Posted
July 26, 2023
Last Updated
August 7, 2023
Sponsor
Amasya University
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1. Study Identification

Unique Protocol Identification Number
NCT05976776
Brief Title
Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas
Official Title
Effectiveness of a Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amasya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Anxiety
Keywords
Maternal Health Needs, Fetal Health Anxiety, Primiparous women, Childbirth and Parenthood Preparation Education, Pregnancy-Related Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized-controlled trial with pretest-posttest control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The Childbirth and Parenthood Preparation Education program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
The Childbirth and Parenthood Preparation Education
Intervention Description
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).
Primary Outcome Measure Information:
Title
Levels of Maternal Health Needs
Description
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.
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Pregnancy-Related Anxiety Levels
Description
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.
Time Frame
1 months
Title
Fetal Health Anxiety Levels
Description
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.
Time Frame
1 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emine İbici Akça, Ph.D
Phone
03582115005-4723
Email
emine.akca@amasya.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine İbici Akça
Organizational Affiliation
Amasya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amasya University
City
Amasya
ZIP/Postal Code
05100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas

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