Mobile Application Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 128 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | AgriIbrahimCecenU | Agri |
Lead Sponsor | Collaborator |
---|---|
Agri Ibrahim Cecen University | Ataturk University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 38-40 weeks of pregnancy. | |
Primary | 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 38-40 weeks of pregnancy. | |
Primary | 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 38-40 weeks of pregnancy. | |
Primary | 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 (38-40 weeks of pregnancy). | |
Primary | 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. |
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