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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06243939
Other study ID # 02.06.2023/134
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2023
Est. completion date September 30, 2025

Study information

Verified date February 2024
Source Cukurova University
Contact Meltem Akbas, PhD
Phone +905065146780
Email makbaskanat@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus.


Description:

This study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus. 24-26 weeks for pregnant women diagnosed with gestational diabetes mellitus. A total of motivational interviews will be held for 4 weeks with the pregnant women. Personal Information Form, Health Management Self-Efficacy Scale and Quality of Life Scale will be administered before the motivational interview, and the Health Management Self-Efficacy Scale and Quality of Life Scale will be administered at the end of the motivational interview.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date September 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Being pregnant for the first time - Being diagnosed with gestational diabetes mellitus - 24-28. Being in the pregnancy week - Being able to speak and understand Turkish - Being 18 years or older - Having a single and viable fetus - Volunteering to participate in research - Having and being able to use a mobile phone - Having all check-ups at the same hospital and regularly throughout pregnancy, Exclusion Criteria: - Being diagnosed with diabetes mellitus (type 1, type 2 diabetes) before pregnancy - Having a psychiatric diagnosis, - Having a chronic disease - Having risk factors such as threat of premature birth, placenta previa, premature rupture of membranes - Having any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than Turkish), - Pregnant women who do not want to continue the study and give birth before the 37th week of pregnancy will be excluded from the study.

Study Design


Intervention

Behavioral:
Motivational Interview to Increase Health Management Self-Efficacy and Quality of Life in Pregnant Women Diagnosed with Gestational Diabetes Mellitus
Motivational interviewing is a client-centered approach used to elicit behavioral change by helping clients explore and resolve their ambivalence.

Locations

Country Name City State
Turkey Meltem Akbas Adana Sariçam

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Efficacy Scale in Health Management Before and after training between the 24th and 26th weeks of pregnancy As the score obtained from the scale increases, self-efficacy for health practices increases.
Primary Quality of Life Scale Before and after training between the 24th and 26th weeks of pregnancy As the total score decreases, the quality of life decreases.
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