Mobile Midwifery Application Offered in the Prenatal Period

NCT06214351 | Completed

• 1 other identifier: Atatürk Uni.
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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 During the follow-up period, 19 participants from the experimental group were withdrawn due to failure to use or deletion of the application (n=10), incomplete questionnaires (n=4), miscarriage (n=3), fetal death (n=1), and preterm labor (n=1). In the control group, 12 participants were withdrawn due to miscarriage (n=4) and incomplete completion of survey forms (n=8).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.

Conditions

Mobile Application

Keywords

Midwife; Prenatal period; Mobile application; Fear of birth; Midwifery care; Readiness

Outcome Measures

Primary Outcomes (5)

• 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).

• 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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group:

NO INTERVENTION

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

Interventions

Use of mobile midwifery application 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 and over, pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead
• Ataturk University: collaborator

Study Sites (1)

AgriIbrahimCecenU

Ağrı, Turkey (Türkiye)

Location

Study Officials

• Ayla KANBUR

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: December 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: April 29, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)