Effects of Education on Stigma and Quality of Life in Individuals With Type 1 Diabetes

NCT ID: NCT06850441

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-02-28

Brief Summary

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This clinical trial aimed to examine the effects of anti-stigma psychoeducation based on the Roy Adaptation Model on stigma and quality of life in individuals with Type 1 Diabetes.The main questions it aims to answer are:

1. Does anti-stigma psychoeducation reduce stigma of individuals diagnosed with Type 1 Diabetes?
2. Does anti-stigma psychoeducation improve the quality of life of individuals diagnosed with Type 1 Diabetes?

Researchers will compare the group that did not receive stigma prevention psychoeducation with those that did.

Participants will receive 7 sessions of the psychoeducation once a week. An evaluation session will be administered 3 months after the psychoeducation.

Researchers will assess all participants' stigma and quality of life before, after and 3 months after the psychoeducation.

Detailed Description

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Individuals who were diagnosed with Type 1 Diabetes at least 6 months ago, are between the ages of 18-75, and can speak and understand the language spoken will be included in the study. Individuals with hearing and visual impairments and those diagnosed with mental retardation will not be included in the study. Participants will be assigned to the intervention and control groups by the statistician through randomization. Each group will consist of 18 people.

Stigma prevention psychoeducation will be applied to the intervention group. This psychoeducation will be conducted as a group education. No intervention will be applied to the control group.

The researcher will evaluate the stigma and quality of life of the intervention and control groups before, after and 3 months after the education. pre-test and post-test and 3-month follow-up Group psychoeducation will be applied to the participants in the intervention group once a week. After the education, they will be evaluated according to the nursing outcome criteria

Conditions

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Diabetes Mellitus, Type I Stigma Quality of Life (QOL)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group to be given group psychoeducation The control group to continue their routine treatments and not receive intervention
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
A diabetes education nurse will identify participants and assign numbers to the identified participants. A statistician will randomize the participant numbers. A different nurse will place the participants in the experimental and control groups according to the numbers.

A statistician will evaluate the results of the education. Thus, the researcher will be blinded in both the participant selection and the outcome evaluation stages.

Study Groups

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Psychoeducation Group

The education is a group psychoeducation. Education methods such as role-play, discussion, demonstration, and narration will be applied. The education will be held once a week and will be completed in 7 weeks.

Psychoeducation topics include adaptation to stigma in type 1 diabetes, coping, diabetes management, social life, self-esteem, roles in life and impact on life. Concepts such as stigma, blame, judgment, discrimination, shame and stereotyped thoughts will be included.

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type OTHER

The education is a group psychoeducation. Education methods such as role-play, discussion, demonstration, and narration will be applied. The education will be held once a week and will be completed in 7 weeks.

Psychoeducation topics include adaptation to stigma in type 1 diabetes, coping, diabetes management, social life, self-esteem, roles in life and impact on life. Concepts such as stigma, blame, judgment, discrimination, shame and stereotyped thoughts will be included.

Control Group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychoeducation

The education is a group psychoeducation. Education methods such as role-play, discussion, demonstration, and narration will be applied. The education will be held once a week and will be completed in 7 weeks.

Psychoeducation topics include adaptation to stigma in type 1 diabetes, coping, diabetes management, social life, self-esteem, roles in life and impact on life. Concepts such as stigma, blame, judgment, discrimination, shame and stereotyped thoughts will be included.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Type 1 diabetes at least 6 months ago,
* Being between the ages of 18 and 75,
* Speaking and understanding Turkish,

Exclusion Criteria

* Having hearing and vision impairment
* Being diagnosed with mental retardation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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Ece MUTLU SATIL

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyda Dülgerler, PhD

Role: STUDY_CHAIR

Ege University

Locations

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Ege University

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type RESULT
PMID: 1593914 (View on PubMed)

Browne JL, Ventura AD, Mosely K, Speight J. Measuring Type 1 diabetes stigma: development and validation of the Type 1 Diabetes Stigma Assessment Scale (DSAS-1). Diabet Med. 2017 Dec;34(12):1773-1782. doi: 10.1111/dme.13507.

Reference Type RESULT
PMID: 28891210 (View on PubMed)

Satil EM, Arabaci LB. Turkish validity and reliability of Type-1 Diabetes Stigma Assessment Scale. North Clin Istanb. 2022 Dec 12;9(6):654-662. doi: 10.14744/nci.2021.36937. eCollection 2022.

Reference Type RESULT
PMID: 36685628 (View on PubMed)

Other Identifiers

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IzmirKCU-SBF-EMS-001

Identifier Type: -

Identifier Source: org_study_id

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