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

NCT05481671 | Unknown

• 1 other identifier: kinesiophobia（fracture)2022.07
• Study Type: observational
• Target: 381
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Fracture

Keywords

Traumatic Fracture; Kinesiophobia; Pain Catastrophizing; Anxiety; Depression; Self-efficacy; Psychological Resilience

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• pain degree

  baseline

• pain degree

  3 days after surgery

• pain catastrophization

  baseline

• pain catastrophization

  3 days after surgery

• anxiety and depression

  baseline

Study Arms (1)

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

Interventions

Questionnaires OTHER

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.

Questionnaires assessed patients with traumatic fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wei XIA, PhD: lead

Study Sites (1)

XIAW

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study subjects are hospitalized patients with traumatic fractures

MeSH Terms

Conditions

Kinesiophobia; Anxiety Disorders; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Wei Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xia, PhD

CONTACT

+86-18823359471; xiaw23@mail.sysu.edu.cn

Yiqing Huang

CONTACT

+86-13794302377; huangyq257@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 1, 2022
• Study Start: October 2, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)