Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients
- Conditions
- Cardiac Diseases Requiring Surgery
- Interventions
- Behavioral: the multidimensional interventions
- Registration Number
- NCT06625892
- Lead Sponsor
- Ai-Ling Chang
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 245
- 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.
- Cognitive impairment,
- Psychiatric disorders, and
- Long-term bedridden patients who rely on others for daily activities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the interventions group the multidimensional interventions The experimental group undergoes a 12-week multidimensional interventions.
- Primary Outcome Measures
Name Time Method kinesiophobia 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).
- Secondary Outcome Measures
Name Time Method International Physical Activity Questionnaire (IPAQ) 1 day discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks. This study uses the short form of the Taiwan version of the IPAQ, developed in collaboration with Liu Ying-Mei and the World Health Organization. It consists of 7 items assessing physical activity over the past week across work, household chores, transportation, and leisure activities, including time and frequency of walking, moderate and vigorous activities, and time spent sitting. The total physical activity is calculated by multiplying each activity category by its corresponding Metabolic Equivalent (MET), execution time, and activity days. An IPAQ score below 600 indicates low physical activity, 600-3000 indicates moderate physical activity, and above 3000 indicates high physical activity. The scale's content validity is 0.994, and its intra-class correlation coefficient is 0.704 (Liou et al., 2008).
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. Professor Yao Kai-Ping developed this questionnaire after obtaining authorization; this questionnaire assesses the quality of life across four domains: physical health, psychological well-being, social relationships, and environment, with 28 items. Each item is scored on a 5-point scale. Scores for each domain are calculated by averaging the scores of the items within that domain and multiplying by 4. Items 3, 4, and 26 are reverse-scored by subtracting the original score from 6. Higher scores indicate a better quality of life. The internal consistency is 0.91, and the content validity of the domains ranges from 0.51 to 0.64 (Taiwan WHOQOL Group, 2000; Yao Kai-Ping, 2002).
Trial Locations
- Locations (1)
Changhua Christian Hospital
🇨🇳Changhua, Taiwan