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临床试验/NCT06587724
NCT06587724招募中不适用

Investigation of the Validity, Reliability, and Responsiveness of the BETY-Biopsychosocial Questionnaire in Individuals Diagnosed with Myositis

Hacettepe University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
BETY-Biopsychosocial Questionnaire

研究概览

简要总结

Individuals diagnosed with myositis have skin, joint, and visceral organ involvement together with proximal muscle weakness, impaired physical function, sexual function, and quality of life also affect individuals psychosocially. Increased anxiety-depression-anxiety problems are observed in individuals, and many factors contributing to these conditions are reported. Therefore, while holistic evaluation of individuals, including these factors, gains importance, more information on how the quality of life changes during the disease is required. There is a need for tools to evaluate these characteristics in individuals disease management and treatment process.

The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed in patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of the improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically evaluates many biopsychosocial characteristics of the individual, such as pain, coping skills, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that holistically evaluate the symptoms mentioned in myositis disease. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic disease, it aimed to examine its validation in this disease group.

This study, which the investigators planned to contribute to this field, aims to investigate BETY-BQ^s validity, reliability, and responsiveness in individuals diagnosed with myositis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Diagnosis of myositis
  • To be over 18 years old
  • Consent of the participant

排除标准

  • Uncontrolled/other clinically significant disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.) individuals with a diagnosis,
  • Pregnant individuals,
  • Individuals with malignancy

结局指标

主要结局

BETY-Biopsychosocial Questionnaire

时间窗: Three months

The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status

次要结局

  • Hospital Anxiety Depression Scale(Three months)
  • Myositis Disease Activity Assessment Tool (MDAAT)(Three months)
  • Health Assessment Questionnaire(Three months)
  • Dermatology Life Quality Index(Three months)
  • Hand Dynamometer(Three months)
  • Timed Up and Go Test(Three months)
  • 30 Seconds Sit to Stand Sest(Three months)
  • 10-Metre Walk Test(Three months)
  • Short Form-36(Three months)
  • Visual Analogue Scale(Three months)
  • Manual Muscle Test-8(Three months)
  • Stair Climb Test(Three months)

研究者

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

Orkun Tüfekçi

Principal Investigator, PT, PhD(c)

Hacettepe University

研究点 (1)

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