Influencing Factors and Their Approach of Kinesiophobia in Patients With Traumatic Fractures

Traumatic Fracture Clinical Trial

Official title:

Influencing Factors and Their Approach of Kinesiophobia in Patients With Traumatic Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481671
• Other study ID #: kinesiophobia(fracture)2022.07
• Status: Recruiting
• Start date: October 2, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2022
• Source: Sun Yat-sen University
• Contact: Wei Xia, PhD
• Phone: +86-18823359471
• Email: xiaw23[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the relationship between kinesiophobia and pain catastrophizing, as well as the relationship between pain catastrophizing and pain level, anxiety and depression, self-efficacy and psychological resilience in patients with traumatic fractures, and to explain the approach and effect relationship between kinesiophobia and these variables.

Description:

At present, there are few studies on kinesiophobia in patients with traumatic fractures. This study adopts structural equation model to analyze the current situation of kinesiophobia in patients with traumatic fractures, and explores the effect of pain level, pain catastrophizing, anxiety and depression, self-efficacy and psychological resilience on kinesiophobia in patients with traumatic fractures, which provides a scientific basis for predicting the occurrence of kinesiophobia in patients with traumatic fractures and developing intervention plans.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 381
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who were diagnosed as fractures due to accidental trauma and were diagnosed by X-rays and clinicians and required surgical treatment.

• Age 18 and above.

Exclusion Criteria:

• Those with a history of chronic pain (pain persisting or indirectly persisting for more than 3 months).

• Those who have serious postoperative complications (such as deep vein thrombosis, infection, etc.) and need other treatment or transfer to another department.

• People with physical disability or abnormal muscle strength before injury.

• Those who have a history of mental illness or who have taken anti-anxiety, depression drugs, or cognitive impairment within one month.

• Patients undergoing emergency surgery on the day of admission.

• Those who cannot communicate normally due to physical or psychological barriers.

Related Conditions & MeSH terms

• Fractures, Bone
• Traumatic Fracture

Intervention

Other:
• Questionnaires
Participants will be asked to respond to the Demographic Information Sheet, Tampa Scale for Kinesiophobia, Numeric Rating Scale, Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale, Resilience Scale , Pain Self-efficacy Questionnaires and Functional Exercise Compliance Scale for Orthopaedic Patients.

Locations

Country	Name	City	State
China	XIAW	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Wei XIA, PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinesiophobia	The kinesiophobia level of patients with traumatic fractures will be measured by Tampa Scale for Kinesiophobia(TSK-11). The total score ranges from 11 to 44. A score of more than 26 on the scale is defined as kinesiophobia.	baseline
Primary	kinesiophobia	The kinesiophobia level of patients with traumatic fractures will be measured by Tampa Scale for Kinesiophobia(TSK-11). The total score ranges from 11 to 44. A score of more than 26 on the scale is defined as kinesiophobia.	3 days after surgery
Primary	functional exercise compliance	The compliance of functional exercise in patients with traumatic fractures will be measured by Functional Exercise Adherence Scale for Orthopaedic Patients. The total score ranges from 15 to 75. A total score of less than or equal to 20 indicates low compliance; a score of greater than or equal to 55 indicates high compliance; and a score of greater than 20 and less than 50 indicates partial compliance.	3 days after surgery
Secondary	pain degree	The pain degree of patients with traumatic fractures will be measured by Numberical Rating Scale. Pain is scored on a scale of 0 to 10, with higher scores indicating higher pain degree.	baseline
Secondary	pain degree	The pain degree of patients with traumatic fractures will be measured by Numberical Rating Scale. Pain is scored on a scale of 0 to 10, with higher scores indicating higher pain degree.	3 days after surgery
Secondary	pain catastrophization	The level of catastrophic pain in patients with traumatic fractures will be measured by Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores indicating higher levels of catastrophic pain in patients.	baseline
Secondary	pain catastrophization	The level of catastrophic pain in patients with traumatic fractures will be measured by Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores indicating higher levels of catastrophic pain in patients.	3 days after surgery
Secondary	anxiety and depression	The anxiety and depression of patients with traumatic fractures will be measured by Hospital Anxiety and Depression Scale . The scale score ranges from 0 to 21 points, 0 to 7 points for no anxiety or depression, 8 to 10 points for suspicious symptoms of anxiety or depression, and greater than or equal to 11 points for psychological disorders.	baseline
Secondary	anxiety and depression	The anxiety and depression of patients with traumatic fractures will be measured by Hospital Anxiety and Depression Scale . The scale score ranges from 0 to 21 points, 0 to 7 points for no anxiety or depression, 8 to 10 points for suspicious symptoms of anxiety or depression, and greater than or equal to 11 points for psychological disorders.	3 days after surgery
Secondary	self-efficacy	The self-efficacy of patients with traumatic fractures will be measured by Pain Self-efficacy Scale. The total score ranges from 0 to 60, with higher scores indicating higher pain self-efficacy.	baseline
Secondary	self-efficacy	The self-efficacy of patients with traumatic fractures will be measured by Pain Self-efficacy Scale. The total score ranges from 0 to 60, with higher scores indicating higher pain self-efficacy.	3 days after surgery
Secondary	psychological resilience	The psychological resilience of patients with traumatic fractures will be measured by Resilience Scale (CD-RISC-10). The total score ranges from 0 to 40, with higher scores indicating higher psychological resilience.	baseline
Secondary	psychological resilience	The psychological resilience of patients with traumatic fractures will be measured by Resilience Scale (CD-RISC-10). The total score ranges from 0 to 40, with higher scores indicating higher psychological resilience.	3 days after surgery