Mobile Midwifery Application Offered in the Prenatal Period

Mobile Midwifery Application: The Effect Of Mobile Midwifery Care Provided During The Prenatal Period On Pregnant Women's Stress, Fear Of Birth, Preparation For Birth, And Satisfaction With Care

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 December 2023 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 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. During the follow-up period, 19 participants from the experimental group were withdrawn due to failure to use or deletion of the application (n=10), incomplete questionnaires (n=4), miscarriage (n=3), fetal death (n=1), and preterm labor (n=1). In the control group, 12 participants were withdrawn due to miscarriage (n=4) and incomplete completion of survey forms (n=8). Due to the exclusion and withdrawal criteria, the study was completed with 107 participants (Experimental: 50, Control: 57). 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.

Study Overview

• Status: Completed
• Conditions: Mobile Application
• Intervention / Treatment: Other: Use of mobile midwifery application

Detailed Description

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), 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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ağrı, Turkey (Türkiye)
    • AgriIbrahimCecenU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Being literate Being 18 years or older Being primigravida Having a single fetus Being in the 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Assessment Form of the Ministry of Health of the Republic of Turkey	With this form, it will be determined whether the pregnant women who will participate in the study are at high risk. Pregnant women in the high risk group will not be included in the study.	It will be filled in at the first meeting with the pregnant woman.
Visual Analogue Patient Satisfaction Scale	The patient satisfaction scale was designed to measure the patient's satisfaction with the given care practices. The scale has numbers from 1 to 10 on a vertical line. Number 1 symbolizes complete dissatisfaction and number 10 symbolizes high level of satisfaction.	It will be taken at 38 week of pregnancy.
Tilburg Pregnancy Distress Scale	It is used to determine distress (stress, anxiety, depression) during pregnancy. The scale consists of a total of 16 items. Each item of the scale is rated as a 4-point Likert type ranging from "very often" (0 points), "quite often" (1 point), "occasionally" (2 points), "rarely or never" (3 points). A total score of 28 or above from the scale enables the diagnosis of pregnant women who are at risk for distress (depression, anxiety, stress).	This form will be collected at the first meeting with the pregnant woman and at 38 week of pregnancy.
Prenatal Self-Assessment Scale- Fear of Birth and Birth Readiness Sub-Dimensions	The scale is used to evaluate the adaptation of pregnant women to pregnancy and motherhood. The "Fear of Birth" and "Readiness for Birth" subscales in the scale will be used. Items are evaluated with scores ranging from "1" to "4" (4: "Describes very much," 3: "Partly describes," 2: "Somewhat describes," 1: Does not describe at all"). The lowest score to be taken separately in the fear of birth and birth readiness sub-dimensions is 10 and the highest score is 40.	This form will be collected at the first meeting with the pregnant woman and at 38 week of pregnancy.
Mobile Application Evaluation Form	This is an evaluation form consisting of 8 questions by which pregnant women participating in the study can evaluate the application.	The questionnaire will be filled out for pregnant women in the experimental group at the end of the study (38 week of pregnancy).

Collaborators and Investigators

• Sponsor: Agri Ibrahim Cecen University
• Collaborators: Ataturk University
• Investigators: Principal Investigator: Ayla KANBUR, Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Readiness; Mobile application; Midwife; Midwifery care; Prenatal period; Fear of birth
• Other Study ID Numbers: Atatürk Uni.

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
• product manufactured in and exported from the U.S.: No