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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06148688
Other study ID # 21-2.1T/39
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2023
Est. completion date December 2023

Study information

Verified date November 2023
Source Izmir Katip Celebi University
Contact Gülsen Isik
Phone +902323293535
Email glsen20@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of digital storytelling intervention on diabetes self-management in women with gestational diabetes. It is a quasi-experimental study with a pretest-posttest control group. The main hypotheses of the study are: Digital storytelling has an impact on women with gestational diabetes' perception of diabetes self-management. Digital storytelling has an impact on the diabetes self-efficacy levels of women with gestational diabetes.


Description:

Women with gestational diabetes who apply to the obstetrics outpatient clinic of the hospital where the study is conducted or who have been hospitalized in the obstetrics clinic and who meet the inclusion criteria will be included in the study. As a result of the G-power analysis, the sample consisted of 21 interventions and 21 control groups. Pre-test data will be collected from pregnant women in both the control and intervention groups through scales. In the hospital where the study was conducted, pregnant women with gestational diabetes are directed to the Endocrine outpatient clinic and receive standard training by the diabetes team. Pregnant women in the intervention group will be shown videos created in addition to the standard training of the institution where the research data were collected. Pregnant women in the intervention group will be shown videos created in addition to the standard training of the institution where the research data were collected. Pregnant women participating in the study will be followed for four weeks. Pre-test data will be collected from pregnant women who meet the sampling criteria within the first week and how the research will proceed will be explained. Four separate videos, created specifically for each determined topic, will be sent to women daily via online environments during the first week and they will be made available for viewing. Once a week, short videos will be sent to the pregnant woman as a reminder and she will be allowed to watch them. Women will be asked to keep records of their blood sugar monitoring results for four weeks. In the fourth week, post-test data from women will be collected through scales. Scales to be used in the research - Introductory Information Form (pre-test) - Diabetes Self-Efficacy Scale (pre-test/post-test) - Perceived Diabetes Self-Management Scale (pre-test/post-test) - International Physical Activity Questionnaire (pre-test/post-test) - Blood Sugar Monitoring Form (post-test)


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being 18 years or older - Being diagnosed with Gestational Diabetes - 24-32. being between weeks of pregnancy - Having a treatment plan made after gestational diabetes diagnosis - Volunteering to participate in the study - Knowing how to read and write Turkish - Not having any pregnancy complications other than Gestational Diabetes - Having a smart phone Exclusion Criteria: -Pregnant women who do not meet the inclusion criteria will be excluded from the study. Moreover; Pregnant women whose blood sugar monitoring was terminated by the doctor during the follow-up, who did not continue hospital checks during the research period or could not be reached, and who experienced preterm labor before the end of the follow-up will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Digital Story
Digital storytelling; It is used in education and training, business marketing, non-profit organizations such as libraries, community centers and museums, and health sciences education. Digital storytelling in health sciences can be a tool for patients and health science professionals to share their experiences, cope with diseases, and add a human element to health problems. In the study, digital stories were created to increase the self-management of pregnant women with gestational diabetes. In creating a digital story; Qualitative studies involving the self-management experiences of women with gestational diabetes have been examined in the literature. Using the results of the studies, scenarios were created that included factors that facilitate and complicate diabetes self-management. The created scenarios were used in the digital storytelling initiative. A total of four long and four short digital story videos were prepared.

Locations

Country Name City State
Turkey Izmir Katip Celebi University Cigli Izmir

Sponsors (2)

Lead Sponsor Collaborator
Izmir Katip Celebi University Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Diabetes Self-Management Scale The Turkish adaptation of the scale, which was adapted and validated by Wallston et al. (2007), was made by Bayindir Çevik (2010).The scale consists of 7 items and is of 5-point likert type.A high total score indicates that the individual's awareness of diabetes management is very good. before and end of the interventions (fourth weeks)
Primary Diabetes Self-Efficacy Scale This scale was developed by Lorig et al. in 2009 to determine the self-efficacy of individuals with diabetes and was adapted into Turkish by Mankan et al. in 2017.The Likert type scale consists of 8 items. The items of the scale have a numbering system between 1 and 10 (1-I do not feel safe at all, 10-I am completely confident).The scale has no cut-off point. As individuals' total scale scores increase, their self-efficacy also increases. before and end of the interventions (fourth weeks)
Primary International Physical Activity Questionnaire The International Physical Activity Questionnaire was designed to detect the physical activity and sedentary lifestyles of adults. Craig et al. (2003) and the Turkish validity and reliability of the questionnaire developed by Öztürk (2005). The questionnaire is recommended for adults aged 18-69. The short-form questionnaire consists of four separate sections and a total of seven questions. The questionnaire includes questions about physical activity performed for at least 10 minutes in the last seven days.
Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. From these calculations, a score in MET-minutes is obtained. One MET-minute; It is calculated by multiplying the minutes of activity performed by the MET score. Walk = 3.3 METs, Moderate physical activity = 4.0 METs, Vigorous physical activity = 8.0 METs
before and end of the interventions (fourth weeks)
Secondary Blood Sugar Monitoring Form Women in the sample group will be asked to record their fasting and 1-hour postprandial blood sugar results in the morning, noon and evening for 4 weeks. The blood sugar monitoring form was prepared by the researcher. first week, second week, third week and fourth week
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