NCT04960475

Study of Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Ankle Sprain

An Observational Study of the Relationship Between Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Chronic Ankle Sprain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study intends to investigate the negative emotions, fear-avoidance beliefs, and quality of life in patients with chronic ankle sprains to explore the relationship between negative emotions such as anxiety and depression, fear-avoidance beliefs, and their impact on quality of life.

Detailed description

Research design: This study is an observational study. It is planned to recruit a total of 120 patients with ankle sprain injury who meet the selection criteria from the Rehabilitation Department of Peking University Third Hospital. They will be divided into an anxiety and depression group and a control group based on anxiety and depression scale. Basic information, anxiety and depression scales, fear-avoidance beliefs score and quality of life score of two groups will be compared and analyzed.

Conditions

• Chronic Ankle Sprain

Interventions

Type	Name	Description
OTHER	Hospital Anxious and Depression(HADS)	The assessment content in the scale is divided into two parts: anxiety and depression. Anxiety is an unexplained state of restlessness, manifested as tension, fear, and panic all day long. Depression is manifested as depression, slow thinking, decreased volition and physical symptoms. The two parts are scored separately. A total score of 0-7 means normal, a total score of 8-10 means mild depression/anxiety, a total score of 11-14 means moderate depression/anxiety, and a total score of 15-21 means severe depression/ anxiety.
OTHER	Fear-Avoidance Belief Questionnaire (FABQ)	FABQ is a self-assessment questionnaire with 16 options. Each option has 7 levels of 0-6 points, representing totally disagree, uncertain, and totally agree; there are 2 subscales, and one subscale measures the fear-avoidance in physical activity, another subscale measures fear-avoidance of work. The final score of FABQ is the superposition of the value of each item. A high score indicates a high level of fear-avoidance beliefs.
OTHER	The MOS 36-Item Short From Health Survey (SF-36)	The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. The SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-07-13
• Last updated: 2021-11-24

Locations

1 site across 1 country: China