- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136052
Kinesiophobia in Children With Headaches
The Effect of Kinesiophobia on Fear of Falling, Quality of Life and Physical Activity in Children With Headache
Introduction: Kinesiophobia is a common symptom associated with high levels of disability and has also been observed in patients with headache. However, the relationship between kinesiophobia and clinical factors in this population is unknown.
Objective: We aimed to investigate the relationship between kinesiophobia and fear of falling, quality of life, and physical activity in children with headache.
Methods: We included 127 children aged 6-18 years with headache complaints in our study. The Tampa Kinesiophobia Scale (TKS) was used to assess kinesiophobia, the International Falls Efficacy Scale (IFSES) was used to assess fear of falling, the International Physical Activity Questionnaire (IPAQ)- short form was used to measure physical activity, and the Quality of Life Scale for Children (QOLS) was used to assess quality of life. A visual analog scale (VAS) was used to assess pain intensity.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kayseri, Turkey, 38030
- Kayseri University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 6-18 years with headache complaints who applied to the pediatric neurology outpatient clinic
- absence of any orthopedic, neurological, etc. disease that would prevent physical activity.
Exclusion Criteria:
- having communication problems
- having a history of additional chronic diseases
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tampa Kinesiophobia Scale (TKS)
Time Frame: 1 day
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Tampa Kinesiophobia Scale consists of 17 questions inquiring about the increase in pain with movement, fear of injury, and avoidance of movement due to pain..
The minimum score is 17 and the maximum score is 68.
A score above 37 points indicates kinesiophobia.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The International Fall Efficacy Scale (FES-I)
Time Frame: 1 day
|
a questionnaire consisting of 16 questions that provide information about the level of fear of falling during daily life activities.
Each question is scored from 1-4 (1= never worried, 2= a little worried, 3= quite worried, 4= very worried).
The total score ranges from a minimum of 16 (no concern) to a maximum of 64 (extremely concerned).
If the score is 24 or above, there is a fear of falling.
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1 day
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Visual Analog Scale
Time Frame: 1 day
|
visual analog scale (VAS), one of the most commonly used, oldest, and best validated scales, was used to measure pain intensity.
According to pain intensity, the scale is usually defined as "no pain" (0 points) and "as bad as possible" or "worst pain imaginable" (10 points).
As the score increases, the pain intensity increases.
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1 day
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the International Physical Activity Questionnaire (IPAQ)
Time Frame: 1 day
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In the questionnaire, respondents report the duration and frequency of their activities in the previous week.
The seven-item questionnaire provides information on time spent on sitting, walking, intermediate activities including sitting, and high-level activities.
A score is calculated by multiplying the number of minutes, the number of days, and the MET value.
For high and moderate physical activity and walking, values of 8 METs, 4 METs, and 3.3 METs are used, respectively. .
The physical activity levels are classified as (< 600 MET-min/week), which is the physically inactive level (level I); (600-3000 MET- min/week), which is the level in medium-level (level II) and (> 3000 MET-min/week), which is the high physical activity level.
The sitting score (sedentary behavior level) is calculated separately.
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1 day
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The Quality of Life Scale for Children (QoLSC)
Time Frame: 1 day
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Measuring the quality of life of the individual with psychological tests is important for determining the quality of life of patients before and after treatment, evaluating the effectiveness and side effects of medical interventions, guiding health policies, and conducting medical research.It takes a value between 0-100 points.
As the score increases, the perception of quality of life increases.
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ozge Baykan Copurgolu, PhD(c), Kayseri University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kinezyofobivebasagrısı
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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