Study of Negative Emotion, Fear-Avoidance Belief and Quality of Life in Patients With Ankle Sprain
23 november 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
140
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Beijing, China
- Peking University Third Hospital
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
FABQ score
Tijdsspanne: 1 hr
|
the total score of Fear-Avoidance Belief Questionnaire
|
1 hr
|
|
SF-36 score
Tijdsspanne: 1 hr
|
the score of SF36 questionnaire
|
1 hr
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Hongying Zhong, Peking University Third Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2021
Primaire voltooiing (Verwacht)
31 december 2021
Studie voltooiing (Verwacht)
31 december 2021
Studieregistratiedata
Eerst ingediend
4 juli 2021
Eerst ingediend dat voldeed aan de QC-criteria
4 juli 2021
Eerst geplaatst (Werkelijk)
13 juli 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 november 2021
Laatste update ingediend die voldeed aan QC-criteria
23 november 2021
Laatst geverifieerd
1 juli 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M2021078
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .