NCT06136052

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

November 9, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

headachekinesiophobiachildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (4)

  • The International Fall Efficacy Scale (FES-I)

    1 day

  • Visual Analog Scale

    1 day

  • the International Physical Activity Questionnaire (IPAQ)

    1 day

  • The Quality of Life Scale for Children (QoLSC)

    1 day

Interventions

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.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • years with headache complaints who applied to the pediatric neurology outpatient clinic
  • absence of any orthopedic, neurological, etc. disease that would prevent physical activity.

You may not qualify if:

  • having communication problems
  • having a history of additional chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri University

Kayseri, 38030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HeadacheKinesiophobia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Ozge Baykan Copurgolu, PhD(c)

    Kayseri University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 18, 2023

Study Start

April 1, 2022

Primary Completion

February 10, 2023

Study Completion

April 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations