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The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge and Anxiety Level

Primary Purpose

Gestational Diabetes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video Education
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Diabetes focused on measuring Oral Glucose Tolerance Test (OGTT), Primiparous Pregnant, Knowledge Level, Anxiety, Nursing

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sağlık Bilimleri Üniversitesi Sarıyer Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education Group

Control Group

Arm Description

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. 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. 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. 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.

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. 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. 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. 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
January 9, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05686694
Brief Title
The Effect of Video Education Given on 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Oral Glucose Tolerance Test (OGTT), Primiparous Pregnant, Knowledge Level, Anxiety, Nursing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blind, randomized controlled, experimental design
Masking
Participant
Masking Description
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 education 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.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education Group
Arm Type
Experimental
Arm Description
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. 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. 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. 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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. 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. 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. 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.
Intervention Type
Other
Intervention Name(s)
Video Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test
Description
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.
Time Frame
before 24. pregnancy weeks and 30-34. pregnancy weeks
Title
State Anxiety Scale
Description
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.
Time Frame
24-28. pregnancy weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Sağlık Bilimleri Üniversitesi Sarıyer Hamidiye Etfal Eğitim ve Araştırma Hastanesi
City
Istanbul
ZIP/Postal Code
34453
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge and Anxiety Level

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