Mobile ApplicationNCT06214351
Mobile Midwifery Application Offered in the Prenatal Period
A study testing Use of mobile midwifery application in people with Mobile Application, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mobile Application
- What is being tested?
- Use of mobile midwifery application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read the 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.
- Conditions
- Mobile Application
- Being tested
- Use of mobile midwifery application
- Keywords
- Midwife, Prenatal period, Mobile application, Fear of birth, Midwifery care, Readiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of mobile midwifery applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: It will be filled in at the first meeting with the pregnant woman.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Dec 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile ApplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Rumeysa ÖZAYABAKAN, Agri Ibrahim Cecen University
- Investigators
- Ayla KANBUR, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214351
- Sponsor's protocol ID
- Atatürk Uni.
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06214351
- Acronym / sponsor ID
- Atatürk Uni.
- Conditions
- Mobile Application
- Keywords
- Midwife, Prenatal period, Mobile application, Fear of birth, Midwifery care, Readiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Use of mobile midwifery applicationA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of mobile midwifery applicationPregnant 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. | Other | Experimental Group |
Primary outcome
Visual Analogue Patient Satisfaction Scale
Time frame: It will be taken at 38 week of pregnancy.
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.
Tilburg Pregnancy Distress Scale
Time frame: This form will be collected at the first meeting with the pregnant woman and at 38 week of pregnancy.
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).
Prenatal Self-Assessment Scale- Fear of Birth and Birth Readiness Sub-Dimensions
Time frame: This form will be collected at the first meeting with the pregnant woman and at 38 week of pregnancy.
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.
Mobile Application Evaluation Form
Time frame: The questionnaire will be filled out for pregnant women in the experimental group at the end of the study (38 week of pregnancy).
This is an evaluation form consisting of 8 questions by which pregnant women participating in the study can evaluate the application.
Risk Assessment Form of the Ministry of Health of the Republic of Turkey
Time frame: It will be filled in at the first meeting with the pregnant woman.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayla KANBUR principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of mobile midwifery application in people with Mobile Application, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Patient Satisfaction Scale (time frame: It will be taken at 38 week of pregnancy.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.