Study of Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Ankle Sprain
NCT ID: NCT04960475
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
140 participants
OBSERVATIONAL
2021-01-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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A/D group
Chronic ankle sprain patient with anxity or depression
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.
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.
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.
Control group
Chronic ankle sprain patient with no emotional issues
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* age 18-50 years;
* no pain in daily activities, or a numerical rating scale (NRS) 6 points or less;
* no mechanical instability of the ankle joint and obvious restriction in joint movement ;
* agree to participate in this study.
Exclusion Criteria
* new or unhealed lower limb fractures;
* history of lower limb surgery within 3 months;
* lower limb pain caused by other diseases (such as lumbar disease, vascular disease, etc.);
* speech and cognitive impairment
* other diseases that cannot participate in this study.
18 Years
80 Years
ALL
Yes
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Hongying Zhong
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, , China
Countries
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Other Identifiers
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M2021078
Identifier Type: -
Identifier Source: org_study_id