Clinical trial NCT06214351: Mobile Midwifery Application Offered in the Prenatal Period
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Application
Keywords: Midwife
Prenatal period
Mobile application
Fear of birth
Midwifery care
Readiness
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2024-01-19
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Patient Satisfaction Scale
timeFrame: It will be taken at 38-40 weeks of pregnancy.
measure: Tilburg Pregnancy Distress Scale
timeFrame: This form will be collected at the first meeting with the pregnant woman and at 38-40 weeks of pregnancy.
measure: Prenatal Self-Assessment Scale- Fear of Birth and Birth Readiness Sub-Dimensions
timeFrame: This form will be collected at the first meeting with the pregnant woman and at 38-40 weeks of pregnancy.
measure: Mobile Application Evaluation Form
timeFrame: The questionnaire will be filled out for pregnant women in the experimental group at the end of the study (38-40 weeks of pregnancy).
measure: Risk Assessment Form of the Ministry of Health of the Republic of Turkey
timeFrame: It will be filled in at the first meeting with the pregnant woman.
Secondary outcomes:
Other outcomes:
Locations:
city: Ağrı
country: Turkey
facility: AgriIbrahimCecenU
Study officials:
affiliation: Ataturk University
name: Ayla KANBUR
role: PRINCIPAL_INVESTIGATOR
References: