Diabetes MellitusEducationNCT07201623
The Effect Of Web-Based Birth Preparation Education Given To Pregnant Women On Prenatal Attachment And Fear Of Birth
A study testing web-based childbirth preparation education in people with Diabetes Mellitus and Chronic Disease of Cardiovascular System, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
WEB-BASED CHILDBIRTH PREPARATION TRAINING GIVEN TO PREGNANT WOMEN PRENATAL ATTACHMENT AND ITS EFFECT ON FEAR OF CHILDBIRTH Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Chronic Disease of Cardiovascular System
- What is being tested?
- web-based childbirth preparation education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2021to 28 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women who: · Live in Çankırı province, · 18 years of age or older, · Have no vision or hearing problems, · Have not been diagnosed with a high-risk pregnancy, · Between 28 and 32 weeks pregnant, · Able to use the internet on a computer or phone,
- Agree to be monitored via various communication tools (phone, social media), · Have not previously received childbirth preparation training or education from a pregnancy school,
- Volunteer to participate in the study were included in the study.
Who cannot join
- At each stage of the study, pregnant women who refused to participate were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çankiri Karatekin Üniversitesi
Çankırı, Çankırı, 18000
About this study
WEB-BASED CHILDBIRTH PREPARATION TRAINING GIVEN TO PREGNANT WOMEN PRENATAL ATTACHMENT AND ITS EFFECT ON FEAR OF CHILDBIRTH
Read the detailed description
Aim: The aim of this study was to evaluate the effect of web-based childbirth preparation education on prenatal attachment and fear of childbirth.
Materials and methods: This randomized controlled trial was conducted between February 2021 and January 2022 with the participation of 102 pregnant women who met the research criteria in family and community health centers and state hospital in Çankırı city center. Participants in the intervention group were sent 15 and 45-minute video links of the modules in the birth preparation training program uploaded to the web base. The participants' viewing status of the videos was checked weekly, and the duration of the participants in the intervention group watching the training videos for the modules was limited to 6 weeks. Participants in the control group did not receive any intervention other than the routine clinical care they received. The study data were collected with a questionnaire prepared using the "Introductory Information Form", "Maternal Fetal Attachment Scale" and "Wijma Birth Expectancy Scale -A Version". The data obtained in the study were evaluated in the computer environment using the Statistical Package for the Social Sciences 22.0 statistical program.
- Being tested
- web-based childbirth preparation education
- Keywords
- Web-based health education, midwifery care, nursing care, birth preparation, prenatal attachment, fear of childbirth
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based childbirth preparation educationBehavioural
group providing web-based childbirth preparation training
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | group providing web-based childbirth preparation training Receives: Behavioral: web-based childbirth preparation education |
| control group | No intervention | the group that did not receive web-based childbirth preparation education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal-Fetal Attachment (MFA)
Scales have 24 five-point Likert-type items and are self-administered. The scales are scored on a scale of one to five, with five being the most positive statement. Note that the scoring is reversed for Item 22, with 'Definitely yes' scoring one point and 'Definitely no' scoring five points. The mean score is calculated by dividing the sum of the item scores by the number of items answered. Cronbach's alpha for MFA was 0.84 in Cranley's study (1981), min 2,29 max4,63 .
Measured: 24-36 pregnancy week
Secondary outcomes (1)
Wijma Delivery Expectancy/Experience Questionnaire A Version (W-DEQ-A)
The W-DEQ-A is a validated 33-item questionnaire, with scores ranging from 'not at all' (0) to 'extremely' (5), giving a minimum score of 0 and a maximum score of 165. A higher score indicates a more intense fear of childbirth.
Measured: 28-36 pregnancy week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start12 Feb 2021
- Primary completion12 Jan 2022
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Materials and methods: This randomized controlled trial was conducted between February 2021 and January 2022 with the participation of 102 pregnant women who met the research criteria in family and community health centers and state hospital in Çankırı city center. Participants in the intervention group were sent 15 and 45-minute video links of the modules in the birth preparation training program uploaded to the web base. The participants' viewing status of the videos was checked weekly, and the duration of the participants in the intervention group watching the training videos for the modules was limited to 6 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru YILDIRIM, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201623
- Sponsor's protocol ID
- E53449070-779-96
- Acronym
- Education
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I dont know
Publications
Ustunsoz A, Guvenc G, Akyuz A, Oflaz F. Comparison of maternal-and paternal-fetal attachment in Turkish couples. Midwifery. 2010 Apr;26(2):e1-9. doi: 10.1016/j.midw.2009.12.006. Epub 2010 Feb 20.
PubMed 20172635Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
PubMed 9638601
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Web-Based Birth Preparation Education Given To Pregnant Women On Prenatal Attachment And Fear Of Birth
- ClinicalTrials.gov ID
- NCT07201623
- Acronym / sponsor ID
- Education / E53449070-779-96
- Keywords
- Web-based health education, midwifery care, nursing care, birth preparation, prenatal attachment, fear of childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 1 Oct 2025 (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.
WEB-BASED CHILDBIRTH PREPARATION TRAINING GIVEN TO PREGNANT WOMEN PRENATAL ATTACHMENT AND ITS EFFECT ON FEAR OF CHILDBIRTH
Detailed description
Aim: The aim of this study was to evaluate the effect of web-based childbirth preparation education on prenatal attachment and fear of childbirth.
Materials and methods: This randomized controlled trial was conducted between February 2021 and January 2022 with the participation of 102 pregnant women who met the research criteria in family and community health centers and state hospital in Çankırı city center. Participants in the intervention group were sent 15 and 45-minute video links of the modules in the birth preparation training program uploaded to the web base. The participants' viewing status of the videos was checked weekly, and the duration of the participants in the intervention group watching the training videos for the modules was limited to 6 weeks. Participants in the control group did not receive any intervention other than the routine clinical care they received. The study data were collected with a questionnaire prepared using the "Introductory Information Form", "Maternal Fetal Attachment Scale" and "Wijma Birth Expectancy Scale -A Version". The data obtained in the study were evaluated in the computer environment using the Statistical Package for the Social Sciences 22.0 statistical program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Materials and methods: This randomized controlled trial was conducted between February 2021 and January 2022 with the participation of 102 pregnant women who met the research criteria in family and community health centers and state hospital in Çankırı city center. Participants in the intervention group were sent 15 and 45-minute video links of the modules in the birth preparation training program uploaded to the web base. The participants' viewing status of the videos was checked weekly, and the duration of the participants in the intervention group watching the training videos for the modules was limited to 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: web-based childbirth preparation educationgroup providing web-based childbirth preparation training |
| control group | No intervention | –the group that did not receive web-based childbirth preparation education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women who: · Live in Çankırı province, · 18 years of age or older, · Have no vision or hearing problems, · Have not been diagnosed with a high-risk pregnancy, · Between 28 and 32 weeks pregnant, · Able to use the internet on a computer or phone,
- Agree to be monitored via various communication tools (phone, social media), · Have not previously received childbirth preparation training or education from a pregnancy school,
- Volunteer to participate in the study were included in the study.
Key exclusion criteria (1 listed)
- At each stage of the study, pregnant women who refused to participate were excluded from the study.
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 |
|---|---|---|
| web-based childbirth preparation educationgroup providing web-based childbirth preparation training | Behavioural | intervention group |
Primary outcome
Maternal-Fetal Attachment (MFA)
Time frame: 24-36 pregnancy week
Scales have 24 five-point Likert-type items and are self-administered. The scales are scored on a scale of one to five, with five being the most positive statement. Note that the scoring is reversed for Item 22, with 'Definitely yes' scoring one point and 'Definitely no' scoring five points. The mean score is calculated by dividing the sum of the item scores by the number of items answered. Cronbach's alpha for MFA was 0.84 in Cranley's study (1981), min 2,29 max4,63 .
1 secondary outcome
Wijma Delivery Expectancy/Experience Questionnaire A Version (W-DEQ-A)
Time frame: 28-36 pregnancy week
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 1 Oct 2025.
- Background: PubMed 20172635Ustunsoz A, Guvenc G, Akyuz A, Oflaz F. Comparison of maternal-and paternal-fetal attachment in Turkish couples. Midwifery. 2010 Apr;26(2):e1-9. doi: 10.1016/j.midw.2009.12.006. Epub 2010 Feb 20.
- Background: PubMed 9638601Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I dont know
Related trials for Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based childbirth preparation education in people with Diabetes Mellitus and Chronic Disease of Cardiovascular System, run by Çankırı Karatekin 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 3 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 1 Oct 2025. 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?
Maternal-Fetal Attachment (MFA) (time frame: 24-36 pregnancy week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07201623, which also lists 2 linked publications.
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 1 Oct 2025.