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临床试验/NCT06625892
NCT06625892招募中不适用

Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients

Ai-Ling Chang1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2024年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
245
试验地点
1
主要终点
kinesiophobia

研究概览

简要总结

The primary objective of this two-year research project is to investigate the status of activity fear, its related factors, and prognosis in cardiac surgery patients in the first year. Subsequently, the study aims to develop a comprehensive intervention strategy combining exercise with cognitive-behavioral approaches tailored for cardiac surgery patients and assess the effectiveness of this intervention on activity fear, prognosis, and quality of life in the second year.

详细描述

The study uses a convenient sampling method, focusing on patients undergoing cardiac surgery in the cardiac surgery ward of the Central Medical Center. The first-year research adopts a descriptive, correlational, and repeated-measures design, while the second-year research employs an experimental design. Participants are randomly assigned to either the experimental or control group. The experimental group undergoes a 12-week multidimensional interventions, while the control group receives no intervention. Data are collected through structured questionnaires. Data collection occurs at discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

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
Single (Outcomes Assessor)

盲法说明

The outcome assessors dose not know the allocation of groups.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients received cardiac surgery.
  • Aged 18 or above.
  • Clear consciousness and able to communicate in Mandarin or Taiwanese.
  • Willing and consent to participate after being informed of the study purpose and procedures.

排除标准

  • Cognitive impairment,
  • Psychiatric disorders, and
  • Long-term bedridden patients who rely on others for daily activities.

结局指标

主要结局

kinesiophobia

时间窗: 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

Tampa Scale of Kinesiophobia for Heart (TSK Heart) was used for measuring kinesiophobia in this study. The TSK Heart developed by Bäck et al. (2012), assesses fear of movement in patients with coronary artery disease. It comprises four dimensions: exercise avoidance, fear of injury, dysfunctional self-perception, and perceived risk of heart problems, with 17 items. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), and items 4, 8, 12, and 16 are reverse scored. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement. A TSK Heart score below 37 indicates a low fear of movement, while a score of 37 or higher indicates a high fear of movement. The scale\'s intra-class correlation coefficient is 0.83, and its internal consistency (Cronbach\'s alpha) is 0.78 (Bäck et al., 2012).

次要结局

  • International Physical Activity Questionnaire (IPAQ)(1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.)
  • Taiwan Brief Version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)(1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.)

研究者

发起方
Ai-Ling Chang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ai-Ling Chang

Supervisor

Changhua Christian Hospital

研究点 (1)

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