Study of Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Ankle Sprain
2021年11月23日 更新者：Peking University Third Hospital
An Observational Study of the Relationship Between Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Chronic Ankle Sprain
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.
調査の概要
状態
積極的、募集していない
条件
詳細な説明
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.
研究の種類
観察的
入学 (実際)
140
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Beijing、中国
- Peking University Third Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Ankle sprains are the most common injury in everyday life, military training and sports.
Forty percent of people with ankle sprains develop chronic ankle instability, including mechanical ankle instability and functional ankle instability.
Mechanical ankle instability is usually caused by structural changes in the ligamentous tissue around the ankle, kinematic damage, synovial changes or degenerative joint disease.
Functional ankle instability refers to the subjective perception of instability during daily life or sports.
Most patients do not require surgery, and clinical examination reveals only minor swelling and localized pressure pain, but rarely severe structural damage to the joint with limited range of motion and joint instability.
However, many patients with chronic functional instability of the ankle joint due to ankle sprain are unable to resume normal work and life due to emotional anxiety and repeatedly seek medical attention.
説明
Inclusion Criteria:
- Ankle sports injury time> 6 months;
- 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:
- acute inflammation of lower limb joints;
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
A/D group
Chronic ankle sprain patient with anxity or depression
|
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.
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 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.
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|
Control group
Chronic ankle sprain patient with no emotional issues
|
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.
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 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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
FABQ score
時間枠：1 hr
|
the total score of Fear-Avoidance Belief Questionnaire
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1 hr
|
|
SF-36 score
時間枠：1 hr
|
the score of SF36 questionnaire
|
1 hr
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Hongying Zhong、Peking University Third Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年1月1日
一次修了 (予想される)
2021年12月31日
研究の完了 (予想される)
2021年12月31日
試験登録日
最初に提出
2021年7月4日
QC基準を満たした最初の提出物
2021年7月4日
最初の投稿 (実際)
2021年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月24日
QC基準を満たした最後の更新が送信されました
2021年11月23日
最終確認日
2021年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。