Clinical trial NCT05686694: Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
Official title: The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gestational Diabetes
Keywords: Oral Glucose Tolerance Test
Primiparous Pregnant
Knowledge Level
Anxiety
Nursing
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, randomized controlled, experimental design
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Reading and understanding Turkish
* literate
* over 18 years old
* under 35 years old
* primiparous pregnant
* before 24 weeks of pregnancy
* having a computer or phone and able to access the internet
* using Instagram
* voluntarily agreed to participate in the study

Exclusion Criteria:

* 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

Primary outcomes:
measure: Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test
timeFrame: before 24. pregnancy weeks and 30-34. pregnancy weeks
measure: State Anxiety Scale
timeFrame: 24-28. pregnancy weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Sarıyer Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Ege University Nursing Faculty
name: Özlem Demirel Bozkurt, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: