HeadacheNCT06136052
Kinesiophobia in Children With Headaches
An observational study of Headache and Kinesiophobia, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Kinesiophobia, Children
- What is being tested?
- Forms
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Apr 2023
- How long will I take part?
- 1 Day
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Data for this cross-sectional study were collected from a convenient sample of patients aged 6-18 years with headache complaints who presented to a tertiary care pediatric neurology outpatient clinic between April 2022 and April 2023.
Who may be able to join
- 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.
Who cannot join
- having communication problems
- having a history of additional chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Data for this cross-sectional study were collected from a convenient sample of patients aged 6-18 years with headache complaints who presented to a tertiary care pediatric neurology outpatient clinic between April 2022 and April 2023. The sampling size was determined as 88 at the beginning of the study and 127 patients were reached in our study. The inclusion criteria were determined as patients aged 6-18 years with headache complaints who applied to the pediatric neurology outpatient clinic of a training and research hospital, and the absence of any orthopedic, neurological, etc. disease that would prevent physical activity. The exclusion criteria were determined as having communication problems that would not allow evaluation and having a history of additional chronic diseases that would prevent physical activity. All participants filled out a case evaluation form including demographic information, information about headache complaints, and scores of the questionnaire results. Participants completed the Tampa Kinesiophobia Scale (TKS) for kinesiophobia assessment. The TKS consists of 17 questions inquiring about the increase in pain with movement, fear of injury, and avoidance of movement due to pain. The International Fall Efficacy Scale (IFES) used in our study is a questionnaire consisting of 16 questions that provide information about the level of fear of falling during daily life activities. In our study, the visual analog scale (VAS), one of the most commonly used, oldest, and best validated scales, was used to measure pain intensity. The short form of the International Physical Activity Questionnaire (IPAQ)- consisting of seven questions- was used in our study. In the questionnaire, respondents report the duration and frequency of their activities in the previous week. 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. The Quality of Life Scale for Children (QoLSC) is a general quality of life scale that is widely used in research and evaluates the physical and psychosocial experiences of children between the ages of 2 and 18, independent of illness.
- Conditions
- Headache, Kinesiophobia, Children
- Being tested
- Forms
- Keywords
- headache, kinesiophobia, children
- Medical subject headings
- Headache, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormsOther
All participants filled out a case evaluation form including demographic information, information about headache complaints, and scores of the questionnaire results. Participants completed the Tampa Kinesiophobia Scale (TKS) for kinesiophobia assessment. The International Fall Efficacy Scale (IFES) used in our study is a questionnaire consisting of 16 questions that provide information about the level of fear of falling during daily life activities. In our study, the visual analog scale (VAS), one of the most commonly used, oldest, and best validated scales, was used to measure pain intensity. The short form of the International Physical Activity Questionnaire (IPAQ)- consisting of seven questions- was used in our study. The Quality of Life Scale for Children (QoLSC) is a general quality of life scale that is widely used in research and evaluates the physical and psychosocial experiences of children between the ages of 2 and 18.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale (TKS)
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.
Measured: 1 day
Secondary outcomes (4)
The International Fall Efficacy Scale (FES-I)
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.
Measured: 1 day
Visual Analog Scale
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.
Measured: 1 day
the International Physical Activity Questionnaire (IPAQ)
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.
Measured: 1 day
The Quality of Life Scale for Children (QoLSC)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Apr 2022
- Primary completion10 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Prospective
- Enrolment
- 127 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Baykan Copuroglu, Muğla Sıtkı Koçman University
- Investigators
- Ozge Baykan Copurgolu, PhD(c), Principal investigator, Kayseri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136052
- Sponsor's protocol ID
- Kinezyofobivebasagrısı
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiophobia on Fear of Falling, Quality of Life and Physical Activity in Children With Headache
- ClinicalTrials.gov ID
- NCT06136052
- Acronym / sponsor ID
- Kinezyofobivebasagrısı
- Conditions
- Headache, Kinesiophobia, Children
- Keywords
- headache, kinesiophobia, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 18 Nov 2023 (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.
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.
Detailed description
Data for this cross-sectional study were collected from a convenient sample of patients aged 6-18 years with headache complaints who presented to a tertiary care pediatric neurology outpatient clinic between April 2022 and April 2023. The sampling size was determined as 88 at the beginning of the study and 127 patients were reached in our study. The inclusion criteria were determined as patients aged 6-18 years with headache complaints who applied to the pediatric neurology outpatient clinic of a training and research hospital, and the absence of any orthopedic, neurological, etc. disease that would prevent physical activity. The exclusion criteria were determined as having communication problems that would not allow evaluation and having a history of additional chronic diseases that would prevent physical activity. All participants filled out a case evaluation form including demographic information, information about headache complaints, and scores of the questionnaire results. Participants completed the Tampa Kinesiophobia Scale (TKS) for kinesiophobia assessment. The TKS consists of 17 questions inquiring about the increase in pain with movement, fear of injury, and avoidance of movement due to pain. The International Fall Efficacy Scale (IFES) used in our study is a questionnaire consisting of 16 questions that provide information about the level of fear of falling during daily life activities. In our study, the visual analog scale (VAS), one of the most commonly used, oldest, and best validated scales, was used to measure pain intensity. The short form of the International Physical Activity Questionnaire (IPAQ)- consisting of seven questions- was used in our study. In the questionnaire, respondents report the duration and frequency of their activities in the previous week. 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. The Quality of Life Scale for Children (QoLSC) is a general quality of life scale that is widely used in research and evaluates the physical and psychosocial experiences of children between the ages of 2 and 18, independent of illness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Data for this cross-sectional study were collected from a convenient sample of patients aged 6-18 years with headache complaints who presented to a tertiary care pediatric neurology outpatient clinic between April 2022 and April 2023.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- having communication problems
- having a history of additional chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FormsAll participants filled out a case evaluation form including demographic information, information about headache complaints, and scores of the questionnaire results. Participants completed the Tampa Kinesiophobia Scale (TKS) for kinesiophobia assessment. The International Fall Efficacy Scale (IFES) used in our study is a questionnaire consisting of 16 questions that provide information about the level of fear of falling during daily life activities. In our study, the visual analog scale (VAS), one of the most commonly used, oldest, and best validated scales, was used to measure pain intensity. The short form of the International Physical Activity Questionnaire (IPAQ)- consisting of seven questions- was used in our study. The Quality of Life Scale for Children (QoLSC) is a general quality of life scale that is widely used in research and evaluates the physical and psychosocial experiences of children between the ages of 2 and 18. | Other | – |
Primary outcome
Tampa Kinesiophobia Scale (TKS)
Time frame: 1 day
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.
4 secondary outcomes
The International Fall Efficacy Scale (FES-I)
Time frame: 1 day
Visual Analog Scale
Time frame: 1 day
the International Physical Activity Questionnaire (IPAQ)
Time frame: 1 day
The Quality of Life Scale for Children (QoLSC)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ozge Baykan Copurgolu, PhD(c) principal investigator
Kayseri University
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 Headache and Kinesiophobia, run by Istanbul Arel 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (TKS) (time frame: 1 day). 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 18 Nov 2023.