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临床试验/NCT07027579
NCT07027579尚未招募不适用

The Effect of Nutrition Education Program on the Quality of Life and Chronic Disease Adaptation in Patients With Thyroid Dysfunction

Çanakkale Onsekiz Mart University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Quality of Life Scale for Thyroid Patients (ThyPRO)

研究概览

简要总结

This thesis study is designed to examine the effects of nutrition education provided to individuals with thyroid dysfunction on their quality of life and adaptation to the disease. The data will be collected using the Descriptive Characteristics Form, the Nutrition Attitude Scale, the Quality of Life Scale for Thyroid Patients (ThyPRO), and the Chronic Illness Adherence Scale. The Body Mass Index (BMI) of participating patients will be calculated by the researcher based on measured height and weight. Laboratory values including TSH, free T4, and free T3 will be obtained from the patients' medical records on the day of assessment. Data collection will be conducted in two phases. The study population will consist of all patients diagnosed with thyroid dysfunction who present to Dr. Burhan Nalbantoğlu Hospital. Using the G*Power 3.1.9.2 software, the required sample size was calculated prior to data collection with a 95% confidence level. For correlation analysis, an alpha value of 0.05, an effect size of 0.455, and a statistical power of 95% were assumed, resulting in a minimum sample size of 56 participants (30 per group). Accounting for potential data loss, a total of 60 patients (30 per group) are planned to be included in the sample.

详细描述

This thesis study is designed to examine the effects of nutrition education provided to individuals with thyroid dysfunction on their quality of life and adaptation to the disease. Patients with thyroid disorders are affected both physically and socially due to hormonal imbalances. In this context, the study aims to investigate how dietary habits are shaped and how these habits influence individuals' overall quality of life. Accordingly, the following research questions were addressed:

  • Does the nutrition education provided affect the level of nutritional knowledge in patients with thyroid dysfunction?
  • Does the nutrition education provided improve the quality of life in patients with thyroid dysfunction?
  • Does the nutrition education provided enhance disease adaptation in patients with thyroid dysfunction? Implementation of the Study Prior to the nutrition education, patients will be informed about the purpose of the study, the data collection methods, and the content of the educational topics. Patients who agree to participate in the study will be asked to sign an informed consent form. The Body Mass Index (BMI) of participating patients will be calculated by the researcher based on measured height and weight. Laboratory values including TSH, free T4, and free T3 will be obtained from the patients' medical records on the day of assessment. Data collection will be conducted in two phases.

Phase 1:

All patients who agree to participate in the study (both intervention and control groups) will first be asked to complete the "Descriptive Characteristics Form," the "Nutrition Attitude Scale" to assess their dietary habits, the "ThyPRO Questionnaire" to evaluate thyroid-related quality of life, and the "Chronic Illness Adherence Scale (CIAS)" to assess disease adaptation.

The Body Mass Index (BMI) of each participant will be calculated by the researcher through direct measurement of height and weight. Free T4 and free T3 values will be obtained from the patients' medical records on the day of evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Not having any physical or mental disabilities
  • Not having received such training before
  • Volunteering to participate in the study
  • Be 18 years of age or older.

排除标准

  • Being under 18 years of age.
  • Having cognitive dysfunction.
  • Not volunteering to participate in the study.

结局指标

主要结局

Quality of Life Scale for Thyroid Patients (ThyPRO)

时间窗: Baseline and after 6 months

The "Thyroid-Related Quality of Life Questionnaire - ThyPRO" consists of 12 items. The 12th question stands alone and is analyzed separately. The scale does not yield a total score; instead, each subscale is scored individually on a scale ranging from 0 to 100. Higher scores indicate lower quality of life.

Nutrition Attitude Scale

时间窗: Baseline and after 6 months

The Nutrition Attitude Scale (NAS) is a five-point Likert-type scale rated from "Strongly agree" (5) to "Strongly disagree" (1). The scale consists of 21 items in total-20 positive and 1 negative. The lowest 21 points and the highest 105 points can be obtained from the nutrition attitude scale. Higher scores from the scale; It will reveal that the individuals who filled the scale have a high attitude towards nutrition and those who have low scores have a low attitude towards nutrition. It can be asserted that individuals' high attitude scores towards nutrition are sensitive to weight control and health.

Chronic Illness Adaptation Scale (CIAS)

时间窗: Baseline and after 6 months

The scale consists of 25 items across three sub-dimensions: physical adaptation, social adaptation, and psychological adaptation.The total possible score on the scale is 125. Higher scores on the sub-dimensions and/or the total scale indicate a greater level of adaptation to the disease.

次要结局

未报告次要终点

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naile ALANKAYA

Assoc. Prof

Çanakkale Onsekiz Mart University

研究点 (2)

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