Clinical trial NCT06850441: Effects of Education on Stigma and Quality of Life in Individuals With Type 1 Diabetes
Official title: Effects of Anti-Stigma Psychoeducation Based on Roy Adaptation Model on Stigma and Quality of Life in Individuals With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type I
Stigma
Quality of Life (QOL)
Keywords: Diabetes Mellitus, Type I
Stigma
Quality of life
Roy Adaptation Model
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group to be given group psychoeducation The control group to continue their routine treatments and not receive intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Type 1 Diabetes Stigma Assessment Scale
timeFrame: 0 day, 7 weeks, 3 months
Secondary outcomes:
measure: Short Form-36
timeFrame: 0 day, 7 weeks, 3 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
affiliation: Ege University
name: Seyda Dülgerler, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.