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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Fracture
• Intervention / Treatment: Other: Questionnaires

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 381

Contacts and Locations

• Study Contact: Name: Wei Xia, PhD; Phone Number: +86-18823359471; Email: xiaw23@mail.sysu.edu.cn
• Study Contact Backup: Name: Yiqing Huang; Phone Number: +86-13794302377; Email: huangyq257@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • XIAW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients with traumatic fractures admitted to the Orthopedics Department of the three third-class hospitals in Guangzhou from August 2022 to May 2023.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Questionnaires assessed patients with traumatic fractures; ①Age 18 and above. ②Patients who were diagnosed as fractures due to accidental trauma and were diagnosed by X-rays and clinicians and required surgical treatment. ③Have the normal cognitive ability, expression ability and social participation ability.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Wei XIA, PhD

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Self-efficacy; Traumatic Fracture; Kinesiophobia; Pain Catastrophizing; Psychological Resilience
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: kinesiophobia（fracture)2022.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No