Development of Atılım Kinesiophobia Scale

NCT ID: NCT06278012

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background:

Kinesiophobia or fear of movement, is defined as an excessive and irrational fear of physical movement to avoid painful injury, harm or re-injury. The existing scales measuring kinesiophobia are thought to have some limitations (the difficulty of patients to understand and answer the questions, the presence of questions that are not suitable for the patient's condition). These questionnaires may not have specific questions enough to assess fear of movement in different patient populations.

Aim: The aim of this study is to develop and validate the Turkish Atılım Kinesiophobia Scale.

Material/method:

In the first stage of the study, research on kinesiophobia was reviewed and a total of 38 questions were created for the scale. The questions were submitted to the opinion of 11 experts working in the physiotherapy and rehabilitation field. Then A total of 100 patients with acute and chronic musculoskeletal pain completed the Turkish Atılım Kinesiophobia Scale and Tampa Scale of Kinesiophobia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Kinesiophobia, or fear of movement, is defined as an excessive and irrational fear of physical movement to avoid painful injury, harm or re-injury. The prevalence of kinesiophobia in chronic painful conditions, especially musculoskeletal pain, has been reported to be between 50% and 70%. Pain-induced fear of movement or kinesiophobia negatively affects response to treatment, recovery and mobility in patients with injury, acute-chronic pain and in patients undergoing rehabilitation. Early and accurate detection of the presence of pain-induced fear of movement and education about kinesiophobia will be beneficial in the rehabilitation and recovery processes of patients (treatment processes will be shortened and recovery success will increase). Today, existing scales measuring kinesiophobia are thought to have some limitations. Especially the Tampa Kinesiophobia Scale is one of the most frequently used scales in the literature to assess kinesiophobia. This scale, whose Turkish validity and reliability study was conducted by the project coordinator and his colleagues, is used by many health professionals working in this field, especially physiotherapists in our country. However, in the studies in the literature and in the previous research of the project coordinator, it was determined that there were limitations and deficiencies related to the scale (the difficulty of patients to understand and answer the questions, the presence of questions that are not suitable for the patient's condition, the lack of questions for patient groups with different characteristics, etc.).

For these reasons, it was thought that there was a need to develop a new scale using a simple language that patients could easily understand. The new scale planned to be developed is intended to be able to measure kinesiophobia by including questions for patients with acute, chronic pain, post-surgical pain, neurological and geriatric patients who receive services in the field of physiotherapy and rehabilitation in the clinic. In addition, the scale to be designed is planned to evaluate the patients' fear of movement with biological, psychological and social reasons according to the International Classification of Functioning, Disability and Health (ICF) model.

Method:

This research is planned as a validity and reliability study in which the Turkish Atılım Kinesiophobia Scale will be developed. After the literature review on the subject, a pool of questions appropriate to the content of the ICF, which evaluates kinesiophobia with patient statements taken from the literature, will be created. Considering the differences in the disease status of the patients, questions for different patient groups mentioned before will be selected and created. The prepared question pool will be presented to the expert opinion of 11 people and the scale questions will be clarified. The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group. After the pilot study, item analyses and exploratory factor analysis (EFA) analysis will be performed with a sample size of 5 times the number of questions in the item pool with acute and chronic pain patients. Afterwards, confirmatory factor analysis (CFA) analysis will be performed for the factor structure obtained with a sample size 10 times the number of remaining items (a second study). In addition, a correlation analysis study will be performed with the new scale and TSK scale for test-retest reliability (ICC) and validity. , Inclusion criteria: Young, middle-aged, neurologic, geriatric patients aged 18-70 years with chronic musculoskeletal pain problems after acute injury or surgery will be included.

Exclusion criteria: illiterate patients, patients with cognitive and cooperation problems will not be included in the study.

When the new scale development process is completed, validation studies of the scale on neurological and geriatric patient population will continue. The project outputs are planned to be published as scientific articles within the scope of SCI and as papers in international and national congresses. The project article will be translated into other languages abroad and cultural adaptations will be carried out.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kinesiophobia Acute Pain Chronic Pain Fear of Movement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Young, middle-aged, neurologic, geriatric patients
* aged 18-70 years with chronic musculoskeletal pain problems after acute injury or surgery will be included.

Exclusion Criteria

* patients with cognitive and cooperation problems will not be included in the study.
* illiterate
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atılım University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NAİME ULUG

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayhan Parmaksız, PhD

Role: PRINCIPAL_INVESTIGATOR

İstanbul Sağlık ve Teknoloji Üniversitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atılım University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Naime Uluğ, PT,PhD

Role: CONTACT

+905365434409

Erden Kılıç, MD

Role: CONTACT

+905554158686

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Naime Uluğ, PhD.

Role: primary

+905365434409

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-59394181-604.01.02-32288

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Kinesiophobia in Chronic Neck Pain
NCT06849999 ACTIVE_NOT_RECRUITING
Manual Therapy Behavior Scale in Physiotherapists
NCT07296380 ENROLLING_BY_INVITATION
The Effects of Music on Neck Pain
NCT06285383 COMPLETED NA