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

October 11, 2022 updated by: Wei XIA, PhD
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
381

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
kinesiophobia
Time Frame: baseline
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
Time Frame: 3 days after surgery
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
Time Frame: 3 days after surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain degree
Time Frame: baseline
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
Time Frame: 3 days after surgery
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
Time Frame: baseline
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
Time Frame: 3 days after surgery
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
Time Frame: baseline
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
Time Frame: 3 days after surgery
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
Time Frame: baseline
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
Time Frame: 3 days after surgery
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
Time Frame: baseline
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
Time Frame: 3 days after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei XIA, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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