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

Sponsor
Wei XIA, PhD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05481671
Collaborator
(none)
381
1
10
38.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
381 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
Influencing Factors and Their Approach of Kinesiophobia in Patients With Traumatic Fractures
Anticipated Study Start Date :
Aug 31, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. kinesiophobia [baseline]

    The kinesiophobia level of patients with traumatic fractures will be measured by Tampa Scale for Kinesiophobia. The total score ranges from 17 to 68. A score of more than 37 on the scale is defined as kinesiophobia.

  2. kinesiophobia [3 days after surgery]

    The kinesiophobia level of patients with traumatic fractures will be measured by Tampa Scale for Kinesiophobia. The total score ranges from 17 to 68. A score of more than 37 on the scale is defined as kinesiophobia.

  3. functional exercise compliance [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.

Secondary Outcome Measures

  1. pain degree [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.

  2. pain degree [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. pain catastrophization [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.

  4. pain catastrophization [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.

  5. anxiety and depression [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.

  6. anxiety and depression [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.

  7. self-efficacy [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.

  8. self-efficacy [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.

  9. psychological resilience [baseline]

    The psychological resilience of patients with traumatic fractures will be measured by Resilience Scale (CD-RISC). The total score ranges from 0 to 100, with higher scores indicating higher psychological resilience.

  10. psychological resilience [3 days after surgery]

    The psychological resilience of patients with traumatic fractures will be measured by Resilience Scale (CD-RISC). The total score ranges from 0 to 100, with higher scores indicating higher psychological resilience.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 XIAW Guangzhou Guangdong China 510080

Sponsors and Collaborators

  • Wei XIA, PhD

Investigators

  • Principal Investigator: Wei Xia, PhD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wei XIA, PhD, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05481671
Other Study ID Numbers:
  • kinesiophobia(fracture)2022.07
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wei XIA, PhD, Associate Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022