Skip to main content
OpenTrials
Completed

NCT Number: NCT06136052

Kinesiophobia in Children With Headaches

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kayseri University

Kayseri, 38030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forms

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. the International Physical Activity Questionnaire (IPAQ)

    Time frame: 1 day

    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.

  4. The Quality of Life Scale for Children (QoLSC)

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Official study title

The Effect of Kinesiophobia on Fear of Falling, Quality of Life and Physical Activity in Children With Headache

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.