NCT05976776

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 26, 2023

Last Update Submit

July 2, 2024

Conditions

Keywords

Maternal Health NeedsFetal Health AnxietyPrimiparous womenChildbirth and Parenthood Preparation EducationPregnancy-Related Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 months

Secondary Outcomes (2)

  • Pregnancy-Related Anxiety Levels

    1 months

  • Fetal Health Anxiety Levels

    1 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The Childbirth and Parenthood Preparation Education program

Behavioral: The Childbirth and Parenthood Preparation Education

Control group

NO INTERVENTION

No intervention

Interventions

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).

Experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Literate
  • years old
  • Primigravida
  • Those who volunteered to participate in the research
  • Pregnant women who do not have communication and mental difficulties

You may not qualify if:

  • Those who do not fill out the entire questionnaire
  • Those with risky pregnancy
  • Pregnant women with a previous history of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, 05100, Turkey (Türkiye)

Location

Related Publications (1)

  • Minozzi S, Ambrosi L, Saulle R, Uhm SS, Terplan M, Sinclair JM, Agabio R. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015042. doi: 10.1002/14651858.CD015042.pub2.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Emine İbici Akça

    Amasya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized-controlled trial with pretest-posttest control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr. in the Amasya University Midwifery Department

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 4, 2023

Study Start

September 1, 2023

Primary Completion

March 31, 2024

Study Completion

June 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations