Gestational DiabetesNCT05686694
Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
A study testing Video Education in people with Gestational Diabetes, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of video education on pregnancy for oral glucose tolerance test implementation status, knowledge and anxiety level. The research was planned as a single-blind randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Video Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 22 Apr 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reading and understanding Turkish
- literate
- over 18 years old
- under 35 years old
- primiparous pregnant
- before 24 weeks of pregnancy
Show all 9Show fewer
- having a computer or phone and able to access the internet
- using Instagram
- voluntarily agreed to participate in the study
Who cannot join
- have a diagnosis of chronic diabetes mellitus (DM)
- have an ectopic pregnancy,
- want to leave the study voluntarily,
- in the education group but do not watch all the education videos
- have miscarriage or preterm birth
- pregnant women who do not fill in the all forms in study
- cannot be contacted during the research
- who decide to continue their doctor's checkups in another hospital
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Sarıyer Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Istanbul, 34453
About this study
Official title: The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
This study was planned to examine the effect of video education on pregnancy for oral glucose tolerance test implementation status, knowledge and anxiety level. The research was planned as a single-blind randomized controlled experimental study.
Read the detailed description
Hypothesis; H0: There is no difference between the OGTT knowledge level scores of primiparous pregnant women who received and did not receive video education.
H1: There is a difference between the OGTT knowledge level scores of primiparous pregnant women who received and did not receive video education.
H0: There is no difference between the status of having the OGTT, primiparous pregnant women who received and did not receive video education.
H1: There is a difference between the status of having the OGTT, primiparous pregnant women who received and did not receive video education.
H0: There is no difference between the mean scores of the State Anxiety Scale according to the video education status of the primiparous pregnant women who had OGTT.
H1: There is a difference between the mean scores of the State Anxiety Scale according to the video education status of the primiparous pregnant women who had OGTT.
H1: The anxiety level of pregnant women who had OGTT was lower than those who did not receive video education.
The research was planned as a single-blind randomized controlled experimental study. The homogeneity of the pregnant women in the education and control groups will be ensured according to age, education level and Instagram usage time. Considering the inclusion and exclusion criteria of the study, pregnant women will be divided into education and control groups by stratified randomization method. For this purpose, pregnant women who meet the criteria of the study will be assigned to the training and control group using a computer-assisted randomization program (https://www.random.org/). Pregnant women will not be informed about the groups they are in, and only the researcher will know which group they will be in, and single-blindness will be provided.
Dependent Variables The OGTT knowledge level of the pregnant women, their OGTT implementation status and the State Anxiety Inventory score average constitute the dependent variables of the study.
Independent variables The planned video OGTT training given to primiparous pregnant women constitutes the independent variable of the study.
Intermediate Variables Socio-demographic characteristics of pregnant women (age, occupation, marital status, family type, place of residence for the longest time, education level, income status, husband's occupation, husband's education level, husband's income), obstetric characteristics (gestational week, height, pregnancy Weight gained, family history of diabetes, history of miscarriage, presence of polycystic ovary syndrome), level of OGTT knowledge (the status of receiving information about OGTT, the people from whom they received information, the sufficient amount of information) constitute the intermediate variables of the research.
Informed Consent Form,Questionnaire for Descriptive Characteristics of Pregnants,Intention and Status of OGTT Questionnaire, Knowledge Level Form on Gestational Diabetes and Oral Glucose Tolerance Test (OGTT),State Anxiety Scale, Education Video Evaluation Form (for pilot group), Nickname card will be used in this study.
- Conditions
- Gestational Diabetes
- Being tested
- Video Education
- Keywords
- Oral Glucose Tolerance Test, Primiparous Pregnant, Knowledge Level, Anxiety, Nursing
- Medical subject headings
- Diabetes, Gestational, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video EducationOther
Sharing of Planned Education Videos on Instagram In this research, the platform where planned video education will be shared was determined as "Instagram", which is the most used social media platform by pregnant women. In the Instagram user name "@ogttegitim" account, 6 education videos that will be created and shared.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | 1. Follow-up (<24 weeks): "Questionnaire for Descriptive Characteristics of Pregnants" and "Informed Consent Form" and pretest application "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" will be made.
2. Follow-up (<24. Week): Watching education videos:the education will end in 3 weeks. After that,post-test application "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" will be applied. They will be asked about their intention to have an OGTT.
3. Follow-up (24-28. weeks): (Waiting after 75 mg dose is administered during OGTT): "State Anxiety Scale" will be applied. The OGTT implementation status of the pregnant woman will be recorded.
4. Follow-up (30-34. weeks): 6 weeks after the video education, the "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" post-test application will be made. Receives: Other: Video Education |
| Control Group | No intervention | 1. Follow-up (<24 weeks): "Questionnaire for the Introductory Characteristics of Pregnants" and "Informed Consent Form", and pre-test application "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" will be made. 2. Follow-up (before OGTT implementation at 24-28 weeks): A posttest application will be made"Knowledge Level Form on Pregnancy Diabetes and Oral Glucose Tolerance Test". It will be asked about their intention to have an OGTT. 3. Follow-up (24-28. weeks) (Waiting after 75 mg dose is administered during OGTT):"State Anxiety Scale" will be applied face-to-face while the pregnant woman is waiting after 75 mg dose is administered during the OGTT application while she is with the pregnant woman on the test day. In addition, the OGTT implementation status of the pregnant woman will be recorded. 4. Follow-up (30-34 weeks): The post-test application of the "Knowledge Level Form on Pregnancy Diabetes and Oral Glucose Tolerance Test" will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test
Pregnant women will respond to each information sentence by choosing one of the options "True", "False", "I don't know". It is planned that the form will consist of 25 or 30 items. The state of knowing the items before and after the education will be evaluated with a percentage.
Measured: before 24. pregnancy weeks and 30-34. pregnancy weeks
State Anxiety Scale
During the evaluation, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative feature of the item, and the constant 50 is added to the total score to be obtained. The highest score is 80 and the lowest score is 20. The higher the total anxiety score, the higher the anxiety level of the person completing the inventory.
Measured: 24-28. pregnancy weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start15 Jun 2023
- Primary completion15 Nov 2023
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- single-blind, randomized controlled, experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem D Bozkurt, PhD, Ege University
- Investigators
- Özlem Demirel Bozkurt, Assoc. Prof., Principal investigator, Ege University Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686694
- Sponsor's protocol ID
- EGE-OZLEM-35
- Other IDs
- Gülcan KARABULUT
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We would like to publish it as an article. It has not yet been published in a journal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
- ClinicalTrials.gov ID
- NCT05686694
- Acronym / sponsor ID
- EGE-OZLEM-35
- Conditions
- Gestational Diabetes
- Keywords
- Oral Glucose Tolerance Test, Primiparous Pregnant, Knowledge Level, Anxiety, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 17 Jan 2023 (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.
This study was planned to examine the effect of video education on pregnancy for oral glucose tolerance test implementation status, knowledge and anxiety level. The research was planned as a single-blind randomized controlled experimental study.
Detailed description
Hypothesis; H0: There is no difference between the OGTT knowledge level scores of primiparous pregnant women who received and did not receive video education.
H1: There is a difference between the OGTT knowledge level scores of primiparous pregnant women who received and did not receive video education.
H0: There is no difference between the status of having the OGTT, primiparous pregnant women who received and did not receive video education.
H1: There is a difference between the status of having the OGTT, primiparous pregnant women who received and did not receive video education.
H0: There is no difference between the mean scores of the State Anxiety Scale according to the video education status of the primiparous pregnant women who had OGTT.
H1: There is a difference between the mean scores of the State Anxiety Scale according to the video education status of the primiparous pregnant women who had OGTT.
H1: The anxiety level of pregnant women who had OGTT was lower than those who did not receive video education.
The research was planned as a single-blind randomized controlled experimental study. The homogeneity of the pregnant women in the education and control groups will be ensured according to age, education level and Instagram usage time. Considering the inclusion and exclusion criteria of the study, pregnant women will be divided into education and control groups by stratified randomization method. For this purpose, pregnant women who meet the criteria of the study will be assigned to the training and control group using a computer-assisted randomization program (https://www.random.org/). Pregnant women will not be informed about the groups they are in, and only the researcher will know which group they will be in, and single-blindness will be provided.
Dependent Variables The OGTT knowledge level of the pregnant women, their OGTT implementation status and the State Anxiety Inventory score average constitute the dependent variables of the study.
Independent variables The planned video OGTT training given to primiparous pregnant women constitutes the independent variable of the study.
Intermediate Variables Socio-demographic characteristics of pregnant women (age, occupation, marital status, family type, place of residence for the longest time, education level, income status, husband's occupation, husband's education level, husband's income), obstetric characteristics (gestational week, height, pregnancy Weight gained, family history of diabetes, history of miscarriage, presence of polycystic ovary syndrome), level of OGTT knowledge (the status of receiving information about OGTT, the people from whom they received information, the sufficient amount of information) constitute the intermediate variables of the research.
Informed Consent Form,Questionnaire for Descriptive Characteristics of Pregnants,Intention and Status of OGTT Questionnaire, Knowledge Level Form on Gestational Diabetes and Oral Glucose Tolerance Test (OGTT),State Anxiety Scale, Education Video Evaluation Form (for pilot group), Nickname card will be used in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blind, randomized controlled, experimental design
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: Video Education1. Follow-up (<24 weeks): "Questionnaire for Descriptive Characteristics of Pregnants" and "Informed Consent Form" and pretest application "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" will be made. 2. Follow-up (<24. Week): Watching education videos:the education will end in 3 weeks. After that,post-test application "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" will be applied. They will be asked about their intention to have an OGTT. 3. Follow-up (24-28. weeks): (Waiting after 75 mg dose is administered during OGTT): "State Anxiety Scale" will be applied. The OGTT implementation status of the pregnant woman will be recorded. 4. Follow-up (30-34. weeks): 6 weeks after the video education, the "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" post-test application will be made. |
| Control Group | No intervention | –1. Follow-up (<24 weeks): "Questionnaire for the Introductory Characteristics of Pregnants" and "Informed Consent Form", and pre-test application "Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test" will be made. 2. Follow-up (before OGTT implementation at 24-28 weeks): A posttest application will be made"Knowledge Level Form on Pregnancy Diabetes and Oral Glucose Tolerance Test". It will be asked about their intention to have an OGTT. 3. Follow-up (24-28. weeks) (Waiting after 75 mg dose is administered during OGTT):"State Anxiety Scale" will be applied face-to-face while the pregnant woman is waiting after 75 mg dose is administered during the OGTT application while she is with the pregnant woman on the test day. In addition, the OGTT implementation status of the pregnant woman will be recorded. 4. Follow-up (30-34 weeks): The post-test application of the "Knowledge Level Form on Pregnancy Diabetes and Oral Glucose Tolerance Test" will be made. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Reading and understanding Turkish
- literate
- over 18 years old
- under 35 years old
- primiparous pregnant
Key exclusion criteria (8 listed)
- have a diagnosis of chronic diabetes mellitus (DM)
- have an ectopic pregnancy,
- want to leave the study voluntarily,
- in the education group but do not watch all the education videos
- have miscarriage or preterm birth
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 |
|---|---|---|
| Video EducationSharing of Planned Education Videos on Instagram In this research, the platform where planned video education will be shared was determined as "Instagram", which is the most used social media platform by pregnant women. In the Instagram user name "@ogttegitim" account, 6 education videos that will be created and shared. | Other | Education Group |
Primary outcome
Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test
Time frame: before 24. pregnancy weeks and 30-34. pregnancy weeks
Pregnant women will respond to each information sentence by choosing one of the options "True", "False", "I don't know". It is planned that the form will consist of 25 or 30 items. The state of knowing the items before and after the education will be evaluated with a percentage.
State Anxiety Scale
Time frame: 24-28. pregnancy weeks
During the evaluation, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative feature of the item, and the constant 50 is added to the total score to be obtained. The highest score is 80 and the lowest score is 20. The higher the total anxiety score, the higher the anxiety level of the person completing the inventory.
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 12 Aug 2025.
- Individual participant dataSharing planned: No. We would like to publish it as an article. It has not yet been published in a journal.
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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.
Özlem Demirel Bozkurt, Assoc. Prof. principal investigator
Ege University Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Education in people with Gestational Diabetes, run by Ege 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 9 inclusion and 8 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 12 Aug 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?
Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test (time frame: before 24. pregnancy weeks and 30-34. pregnancy weeks). The study lists 2 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 12 Aug 2025.