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临床试验/NCT06850441
NCT06850441已完成不适用

Effects of Anti-Stigma Psychoeducation Based on Roy Adaptation Model on Stigma and Quality of Life in Individuals With Type 1 Diabetes

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Type 1 Diabetes Stigma Assessment Scale

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Having hearing and vision impairment
  • •Being diagnosed with mental retardation

研究组 & 干预措施

Control Group

No Intervention

No intervention

Psychoeducation Group

Experimental

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.

干预措施: Psychoeducation (Other)

结局指标

主要结局

Type 1 Diabetes Stigma Assessment Scale

时间窗: 0 day, 7 weeks, 3 months

Type 1 Diabetes Stigma Assessment Scale was developed by Browne et al. in 2017 to assess perceived and experienced stigma in adults diagnosed with type 1 diabetes. The scale consists of 19 items. The scale has 3 sub-dimensions; "treated differently", "Blame and judgment" and "Identity concerns" Each item is scored on a 5-point Likert scale. (1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree). Item scores are added to obtain the sub-dimensions and total score of the scale. A high score indicates an increase in perceived and felt stigma.

次要结局

  • Short Form-36(0 day, 7 weeks, 3 months)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ece MUTLU SATIL

Research Assistant

Izmir Katip Celebi University

研究点 (1)

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