- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Esmanur Günal, MSc
- Telefonnummer: +905537066125
- E-mail: esmanurgunal2001@gmail.com
Studiesteder
-
-
Tortum
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Erzurum, Tortum, Tyrkiet (Türkiye), 25430
- Tortum State Hospital
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Kontakt:
- Esmanur Günal, MSc
- Telefonnummer: +905537066125
- E-mail: esmanurgunal2001@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: Usual Care Control Group
Participants will receive standard diabetes care without additional intervention.
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Usual Care Control Group
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in self-management behavior score
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Seda Başak, PhD, Atatürk University, Faculty of Nursing
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AtaturkUnurse
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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