Traumatic FractureNCT05481671
Influencing Factors and Their Approach of Kinesiophobia in Patients With Traumatic Fractures
An observational study of Traumatic Fracture, run by Wei XIA, PhD at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Fracture
- What is being tested?
- Questionnaires
- How many people
- 381 participants
- Where
- 1 siteChina
- Study dates
- 2 Oct 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XIAW
Guangzhou, Guangdong, 510080
Wei Xia, PhD, 18823359471, xiaw23@mail.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Traumatic Fracture
- Being tested
- Questionnaires
- Keywords
- Traumatic Fracture, Kinesiophobia, Pain Catastrophizing, Anxiety, Depression, Self-efficacy, Psychological Resilience
- Medical subject headings
- Kinesiophobia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 days after surgery
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start2 Oct 2022
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 381 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481671
- Sponsor's protocol ID
- kinesiophobia（fracture)2022.07
- Status last verified
- Oct 2022
- First submitted
- 24 Jul 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors and Their Approach of Kinesiophobia in Patients With Traumatic Fractures
- ClinicalTrials.gov ID
- NCT05481671
- Acronym / sponsor ID
- kinesiophobia（fracture)2022.07
- Conditions
- Traumatic Fracture
- Keywords
- Traumatic Fracture, Kinesiophobia, Pain Catastrophizing, Anxiety, Depression, Self-efficacy, Psychological Resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed patients with traumatic fractures | – | Other: Questionnaires①Age 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants 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. | Other | Questionnaires assessed patients with traumatic fractures |
Primary outcome
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.
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.
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.
10 secondary outcomes
pain degree
Time frame: baseline
pain degree
Time frame: 3 days after surgery
pain catastrophization
Time frame: baseline
pain catastrophization
Time frame: 3 days after surgery
anxiety and depression
Time frame: baseline
anxiety and depression
Time frame: 3 days after surgery
self-efficacy
Time frame: baseline
self-efficacy
Time frame: 3 days after surgery
psychological resilience
Time frame: baseline
psychological resilience
Time frame: 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Fracture, run by Wei XIA, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (+86-18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinesiophobia (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.