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临床试验/NCT05971797
NCT05971797已完成不适用

Rational-emotional Behavioral Therapy in Patients With Osteoarthritis and Concomitant Diseases Before Knee or Hip Arthroplasty

Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
2
主要终点
STAI

研究概览

简要总结

The objective of this study was evaluation of the effectiveness of REBT on the emotional state of orthopedic patients with comorbidities before and after arthroplasty.

详细描述

The studies assessed depression or anxiety in orthopedic patients by using Spielberger State-Trait Anxiety Inventory (STAI) and Hospital Anxiety and Depression Scale (HADS) before and after athroplasty. The comorbid background studied. The orthopedic patients with comorbidities were divided into several groups: arterial hypertension, chronic pyelonephritis , varicose veins, cardiovascular disease and atherosclerosis, diabetes mellitus, infection diseases, gastrointestinal diseases, obesity, neurological disorder, cerebrovascular accident, iron deficiency anemia, chronic bronchitis, hyperthyroidism, cardiac arrhythmia, other diseases. Patients with high levels of anxiety and depression underwent Rational Emotive Behavior Therapy before surgery. Patients without comorbidities and patients with comorbidities but without exposure considered as a control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
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

  • Patients enrolled for the primary knee or hip arthroplasty (M15.0, M16, M17) before operation.

排除标准

  • Other types of psychiatric pathology
  • Reluctance to undergo psychological correction
  • Failure to pass pre-test
  • Ongoing follow-up with a psychologist or psychiatrist

结局指标

主要结局

STAI

时间窗: 2 days after surgery

Each subscale uses a 4-point Likert scale with a range from 1 ("not at all" for S- or "almost never" for T-Anxiety) to 4 ("very much so" for S- and "almost always" for T-Anxiety). Reverse scoring is used for anxiety-absent items (e.g., "I feel calm" or "I am happy"), and therefore, a higher score indicates more severe anxiety with a potential range from 20 to 80 for each subscale. According to the developer scores of 20-39, 40-59, and 60-80 indicate low, moderate, and high anxiety, respectively. Normative values are available in the manual.

HADS

时间窗: 2 days after surgery

The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). with a range from 0 ("not at all") to 3 ("most of the time"). Reverse scoring is used for items with positive wording (e.g., "I still enjoy the things I used to enjoy"). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score of 8-10 should be classified as a mild disorder, 11-15 as a moderate disorder, and 16 or more as a severe disorder.

次要结局

未报告次要终点

研究者

发起方
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emelianov Vladimir

MD PhD Clinical Assistant Professor

Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

研究点 (2)

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