KinesiophobiaNCT06278012
Development of Atılım Kinesiophobia Scale
An observational study of Kinesiophobia and Acute Pain, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kinesiophobia, Acute Pain, Chronic Pain
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Mar 2024
- How long will I take part?
- 2 Weeks
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of male and female patients aged 18-70 years with complaints of acute and chronic pain due to musculoskeletal problems.
Who may be able to join
- Young, middle-aged, neurologic, geriatric patients
- aged 18-70 years with chronic musculoskeletal pain problems after acute injury or surgery will be included.
Who cannot join
- patients with cognitive and cooperation problems will not be included in the study.
- illiterate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atılım University
Ankara
Naime Uluğ, PhD., +905365434409, naime.ulug@atilim.edu.tr
About this study
Official title: Development, Validity and Reliability of Atılım Kinesiophobia Scale
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.
Read more
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.
Read the detailed description
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
- Kinesiophobia, Acute Pain, Chronic Pain, Fear of Movement
- Keywords
- pain, fear of movement, kinesiophobia, Turkish scale
- Medical subject headings
- Kinesiophobia, Acute Pain, Chronic Pain, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group.
Measured: Up to one month
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.
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2024
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAİME ULUG, Atılım University
- Investigators
- Ayhan Parmaksız, PhD, Principal investigator, İstanbul Sağlık ve Teknoloji Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278012
- Sponsor's protocol ID
- E-59394181-604.01.02-32288
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validity and Reliability of Atılım Kinesiophobia Scale
- ClinicalTrials.gov ID
- NCT06278012
- Acronym / sponsor ID
- E-59394181-604.01.02-32288
- Conditions
- Kinesiophobia, Acute Pain, Chronic Pain, Fear of Movement
- Keywords
- pain, fear of movement, kinesiophobia, Turkish scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of male and female patients aged 18-70 years with complaints of acute and chronic pain due to musculoskeletal problems.
Key inclusion criteria (2 listed)
- Young, middle-aged, neurologic, geriatric patients
- aged 18-70 years with chronic musculoskeletal pain problems after acute injury or surgery will be included.
Key exclusion criteria (2 listed)
- patients with cognitive and cooperation problems will not be included in the study.
- illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group.
Time frame: Up to one month
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.
Time frame: Up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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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.
Ayhan Parmaksız, PhD principal investigator
İstanbul Sağlık ve Teknoloji Üniversitesi
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 Kinesiophobia and Acute Pain, run by Atılım University at 1 site in Turkey (Türkiye).
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 2 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 1 Apr 2024. 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 Turkey (Türkiye). 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 Naime Uluğ, PT,PhD (+905365434409, ulugnaime@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group. (time frame: Up to one month). The study lists 2 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 1 Apr 2024.