NCT06332924

Brief Summary

The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences. This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Keywords

Positive birthMotivational interviewing trainingPrimiparous pregnant womenPerception of traumatic birth

Outcome Measures

Primary Outcomes (1)

  • Primipara Pregnant Women and Traumatic Birth

    motivational interviewing

    Once a week for 3 weeks

Study Arms (2)

Motivational interviewing group

EXPERIMENTAL

The patients in the intervention group will be informed about the study, and after the purpose and method of the study are explained, their consent will be obtained and the "Pregnant Information Form" will be applied. * There will be 3 meetings for both groups, one week apart. Interviews will include primipara pregnant women in their 30th, 32nd and 34th weeks of pregnancy. * Preliminary tests will be conducted before the interviews. * After the interviews are completed, final tests will be carried out and the study will be terminated. * Motivational Interviewing Training for the intervention group will be prepared in detail, with the aim of answering the pregnant woman's questions, and with methods that are relevant to her needs and interests by providing body awareness.

Behavioral: motivational discussion group

Control group:

NO INTERVENTION

Scales will be applied to the control group as pre-test and post-test with a 2-week interval.

Interventions

There will be 3 interviews with the motivational interview group, one week apart.

Also known as: control group
Motivational interviewing group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • enzel köksaldı

    SağlıkBilimleriU

    STUDY DIRECTOR

Central Study Contacts

enzel köksaldı

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

April 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03