Mobile Midwifery Application Offered in the Prenatal Period

NCT ID: NCT06214351

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-10-15

Brief Summary

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In this study, the development of a mobile application for prenatal midwifery care and the examination of the effect of the developed mobile application on the stress, fear of childbirth, readiness for childbirth, and satisfaction with care of pregnant women are aimed. The research has a randomized controlled experimental design. Research data will be collected between January 2024 and October 2024 at the Obstetrics and Gynecology Clinic of Ağrı Training and Research Hospital. The universe of the research will consist of pregnant women who apply to the NST unit and Obstetrics and Gynecology Clinic of the relevant hospital. The sample of the research consists of pregnant women who meet the inclusion criteria and volunteer to participate in the research. A priori power analysis was conducted to determine the sample size of the research. Cohen's standardized effect size reference method was selected in the power analysis. It was calculated that 102 pregnant women (Experimental group: 51, Control group: 51) should be included in order to achieve 80% power with a 95% confidence interval at a significance level of 0.05. In order to account for possible data losses, it was decided to collect data from a total of 128 individuals by including an additional 25% reserve sample in this number. The sample of the research will be selected by randomization among those who meet the specified research criteria. The assignment of participants to the experimental and control groups will be done through randomization. For randomization, the Random Integer Generator method in the Numbers subheading of the https://www.random.org site will be used to create single-group columns between 1 and 128 in the system. In the data collection stage of the study, an Introductory Information Form, Risk Assessment Form of the Ministry of Health of the Republic of Turkey, Visual Analog Patient Satisfaction Scale, Tilburg Pregnancy Distress Scale, Prenatal Self-Evaluation Scale - Fear of Childbirth and Sub-dimensions of Readiness for Childbirth, and Mobile Application Evaluation Form will be used.

Detailed Description

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Experimental Group: Pregnant women in the experimental group will have a mobile application installed on their smartphones.

Control Group: Pregnant women in the control group will receive routine antenatal care.

Pregnant women who meet the inclusion criteria of the study will be provided with information about the purpose, content, and application of the study. Pregnant women in the experimental and control groups will be included in the study. At this stage, both groups will fill out the Personal Information Form, the Birth Fear and Birth Readiness sub-scales of the Prenatal Self-Evaluation Scale, the Tilburg Pregnancy Distress Scale, and the Risk Assessment Form of the Ministry of Health of the Republic of Turkey.

At the end of the information process, informed consent will be obtained from pregnant women. Pregnant women will be assigned to experimental and control groups using a simple random table from the www.random.org website.

In the last trimester of pregnancy (weeks 38-40), the Birth Fear and Readiness sub-scales of the Prenatal Self-Assessment Scale, Visual Analog Patient Satisfaction Scale, and Tilburg Pregnancy Distress Scale will be administered to both the control and experimental groups. Pregnant women in the experimental group will also complete the mobile application evaluation form.

Conditions

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Mobile Application

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mobile midwifery application is a mobile application based on the prenatal process, where pregnant women can get information about pregnancy, birth and postpartum processes.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

A mobile application will be installed on the smartphones of the pregnant women in the experimental group.

The mobile application will be installed on the phones of the pregnant women in the experimental group. (The mobile application will be downloaded from the "Play Store" for Android users and from the "App Store" for iOS users). Information about the application will be provided and any questions from the pregnant women will be answered. Pregnant women will be free to access the application at any time during the study.

Group Type EXPERIMENTAL

Use of mobile midwifery application

Intervention Type OTHER

Pregnant women in the experimental group will have a mobile midwifery application installed on their smartphones. The pregnant woman will be able to reach the research midwife 24/7. With the informative content and algorithm mechanism in the application, she will be able to provide individual care and detect early signs of danger, enabling her to seek medical attention.

Control Group:

Pregnant women in the control group will receive routine antenatal care. Routine antenatal care will be provided to pregnant women in the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of mobile midwifery application

Pregnant women in the experimental group will have a mobile midwifery application installed on their smartphones. The pregnant woman will be able to reach the research midwife 24/7. With the informative content and algorithm mechanism in the application, she will be able to provide individual care and detect early signs of danger, enabling her to seek medical attention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Being literate Being 18 years or older Being primigravida Having a single fetus Being in the first and second trimester of pregnancy Having a smartphone and having the ability to use it effectively Having internet access Being open to communication Not having a diagnosed psychiatric disease Volunteering to participate in research

Exclusion Criteria

Being illiterate Being multiparous Having a High Risk Pregnancy according to the "Risk Assessment Form" of the Ministry of Health of the Republic of Turkey Having a diagnosed psychiatric disorder don't have a disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role collaborator

Agri Ibrahim Cecen University

OTHER

Sponsor Role lead

Responsible Party

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Rumeysa Taskin

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayla KANBUR

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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AgriIbrahimCecenU

Ağrı, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Atatürk Uni.

Identifier Type: -

Identifier Source: org_study_id

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