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- Klinische proef NCT07617766
Mindfulness Training in Type 2 Diabetes (MindfulT2DCA)
The Effect of Mindfulness-Based Self-Management Education on Diabetes-Related Difficulties and Empowerment in Individuals With Type 2 Diabetes
This study aims to evaluate the effects of mindfulness-based self-management education on diabetes-related difficulties and empowerment in individuals with type 2 diabetes. Participants will receive a structured education program designed to improve self-care behaviors, emotional well-being, and confidence in managing their condition.
The program includes mindfulness practices, diabetes self-management education, and supportive group sessions. Outcomes such as diabetes distress, self-management behaviors, and patient empowerment will be measured before and after the intervention.
The findings of this study are expected to contribute to improving patient-centered care and supporting individuals with type 2 diabetes in managing their health more effectively.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Type 2 diabetes is a chronic condition that requires continuous self-management, including medication adherence, lifestyle modification, and emotional coping. Many individuals experience diabetes-related difficulties, reduced motivation, and challenges in maintaining long-term self-care behaviors. Mindfulness-based approaches have been shown to improve emotional regulation, stress management, and self-efficacy in individuals with chronic illnesses.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based self-management education program in individuals with type 2 diabetes. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured program consisting of mindfulness practices, diabetes education, and group-based support sessions. The control group will receive usual care.
Primary outcomes include diabetes-related difficulties and patient empowerment. Secondary outcomes include self-care behaviors, emotional well-being, and perceived quality of life. Data will be collected at baseline and after completion of the intervention using validated assessment tools.
This study aims to provide evidence on whether integrating mindfulness into diabetes self-management education can improve both psychological and behavioral outcomes, thereby enhancing overall diabetes care and patient well-being.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Esmanur Günal, MSc
- Telefoonnummer: +905537066125
- E-mail: esmanurgunal2001@gmail.com
Studie Locaties
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Tortum
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Erzurum, Tortum, Turkije (Türkiye), 25430
- Tortum State Hospital
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Contact:
- Esmanur Günal, MSc
- Telefoonnummer: +905537066125
- E-mail: esmanurgunal2001@gmail.com
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Aged between 18 and 65 years.
Diagnosed with Type 2 diabetes mellitus.
Literate (able to read and write).
Has access to and is able to actively use a smartphone or internet.
No diagnosed mental or cognitive impairment.
Willing to participate voluntarily and provide informed consent.
Exclusion Criteria:
- Previously received structured education related to their diabetes.
Pregnant.
Currently participating in another research study.
Hospitalized due to diabetes-related complications.
Unable to complete the education program.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Mindfulness-Based Self-Management Education Group
Participants will receive a structured mindfulness-based self-management education program in addition to usual care.
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A structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions
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Actieve vergelijker: Usual Care Control Group
Participants will receive standard diabetes care without additional intervention.
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Usual Care Control Group
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in self-management behavior score
Tijdsspanne: Baseline to 8 weeks
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Measured using a validated self-management questionnaire
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Baseline to 8 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Seda Başak, PhD, Atatürk University, Faculty of Nursing
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AtaturkUnurse
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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