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临床试验/NCT07298837
NCT07298837已完成不适用

The Effect of Turtle Therapy on HbA1c and Self-Efficacy Levels in Diabetes Medication Use in Individuals With Type 2 Diabetes: A Double-Blind Randomized Controlled Study

Karadeniz Technical University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Hemoglobin A1c

研究概览

简要总结

This study examined the effect of live and video turtle therapy on hemoglobin A1c tests and self-efficacy levels in adults with Type 2 Diabetes Mellitus for the first time using pre-test and post-test methods.

详细描述

In the international literature reviewed, only two studies reported that pet therapy reduced hemoglobin A1c tests and increased self-efficacy in adolescents with Type 1 Diabetes Mellitus. One study examined the use of live fish (repeated care behaviors during pet care, such as feeding twice a day and cleaning the aquarium). In the other study, adolescents who owned different types of pets (dogs, cats, birds, fish, reptiles, amphibians, rodents, etc.) were included in the study. In this context, our study will be the first study conducted in individuals with Type 2 Diabetes Mellitus using live and video turtle therapy at the national and international level. With the theoretical clarification of the methodological steps, this study, which has methodological characteristics, is unique in that it compares live animal (turtle) and video animal (turtle video) therapy in individuals with Type 2 Diabetes Mellitus, making it a pet therapy study conducted both nationally and internationally in both turtles and individuals with Type 2 Diabetes Mellitus. Within the scope of all this information, this study examined the effect of live and video turtle therapy on hemoglobin A1c and self-efficacy levels in adults with Type 2 Diabetes Mellitus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Being 18 years of age or older,
  • Agreement to participate in the study,
  • Being literate,
  • Being able to communicate verbally,
  • No vision, hearing, or speech impairments,
  • Agreeing to adopt and care for a turtle (turtle group),
  • Ownership of a smartphone, tablet, or computer (video turtle group),
  • Having been diagnosed with T2DM and having been receiving DM treatment for at least 6 months,
  • HbA1c >7%.

排除标准

  • Refusal to participate in the study,
  • Not having T2DM,
  • Having received DM treatment for less than 6 months,
  • Having a psychiatric disorder diagnosed by a psychiatrist.

结局指标

主要结局

Hemoglobin A1c

时间窗: 12 week

Hemoglobin A1c is a clinically useful index of average blood glucose levels over the past 120 days (average red blood cell lifespan). It most accurately reflects glycemic control over the past 2-3 months. Hemoglobin A1c was measured twice, before and after the study.

Diabetes Medication Self-Efficacy Scale

时间窗: 12 week

Diabetes Medication Self-Efficacy Scale was developed by Sleath and colleagues (2016) to assess self-efficacy in overcoming barriers to diabetes medication use. Its Turkish validity and reliability were established by Kavuran \& Türkoğlu (2022) using a 19-item, 3-point Likert-type scale. The scale consists of three subscales: "Requirement" (items 1-4), "Busyness" (items 5-9), and "Worry" (items 10-19). The scale scores range from 19 (low self-efficacy) to 57 (high self-efficacy). Diabetes Medication Self-Efficacy Scale was measured twice, before and after the study.

Hemoglobin A1c

时间窗: 12 week

Hemoglobin A1c is a clinically useful index of average blood glucose levels over the past 120 days (average red blood cell lifespan). It most accurately reflects glycemic control over the past 2-3 months. Hemoglobin A1c was measured twice, before and after the study.

Diabetes Medication Self-Efficacy Scale

时间窗: 12 week

Diabetes Medication Self-Efficacy Scale was developed by Sleath and colleagues (2016) to assess self-efficacy in overcoming barriers to diabetes medication use. Its Turkish validity and reliability were established by Kavuran \& Türkoğlu (2022) using a 19-item, 3-point Likert-type scale. The scale consists of three subscales: "Requirement" (items 1-4), "Busyness" (items 5-9), and "Worry" (items 10-19). The scale scores range from 19 (low self-efficacy) to 57 (high self-efficacy). Diabetes Medication Self-Efficacy Scale was measured twice, before and after the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Demirağ, Ph.D

Assistant Professor

Karadeniz Technical University

研究点 (2)

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