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临床试验/NCT07292129
NCT07292129已完成不适用

Smartphone Addiction as a Modifiable Factor in Cervicogenic Headache: Effects on Pain, Function, Mood, and Sleep

Gulseren Demir Karakilic1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年6月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
Smartphone Addiction Scale - Short Form

研究概览

简要总结

Cervicogenic headache is a secondary headache disorder that originates from the cervical spine and often presents with pain radiating from the neck to the head, reduced functional capacity, and impaired quality of life. In modern society, prolonged smartphone use and dependence are increasingly recognized as potential contributors to musculoskeletal problems, poor posture, psychological distress, and sleep disturbances.

This study was designed as a case-control investigation to explore the relationship between smartphone addiction (problematic smartphone use) and clinical characteristics of cervicogenic headache in comparison with healthy individuals. Participants were evaluated in the outpatient clinics of Physical Medicine and Rehabilitation and Neurology at Yozgat Bozok University.

A structured sociodemographic form was administered, and each participant completed a set of validated assessment tools. Smartphone use behavior was assessed with the Smartphone Addiction Scale-Short Form. Headache-related disability was measured with the Headache Impact Test. Cervical function was evaluated with the Neck Disability Index. Psychological status was assessed using the Hospital Anxiety and Depression Scale. Sleep quality was examined with the Jenkins Sleep Scale. Health-related quality of life was measured using the 12-item Short Form Health Survey, and pain intensity was evaluated with the Visual Analog Scale.

The study was conducted in accordance with the Declaration of Helsinki. Approval was obtained from the Clinical Research Ethics Committee, and written informed consent was provided by all participants prior to enrollment.

详细描述

Cervicogenic headache is a secondary headache that arises from dysfunction or pathology of the cervical spine and associated structures. It is characterized by unilateral head and neck pain, which may radiate to the frontal or temporal regions and is often aggravated by neck movements. Cervicogenic headache is known to cause substantial functional disability, emotional distress, and reduced quality of life.

With the rapid increase in smartphone use worldwide, attention has been drawn to its possible musculoskeletal and psychological consequences. Prolonged forward head posture, repetitive neck movements, and excessive screen time may contribute to cervical dysfunction and exacerbate symptoms of cervicogenic headache. In addition, behavioral dependence on smartphones has been associated with mood disorders, sleep disturbances, and impaired daily functioning. Understanding the potential role of smartphone addiction as a modifiable factor in cervicogenic headache is therefore of clinical importance.

The present study was designed as a case-control observational protocol to investigate the association between smartphone addiction and clinical outcomes in individuals with cervicogenic headache compared with healthy controls. Data were collected in the outpatient clinics of Physical Medicine and Rehabilitation and Neurology at Yozgat Bozok University.

A standardized sociodemographic form was administered, followed by a comprehensive set of validated assessment instruments. These included the Smartphone Addiction Scale-Short Form to evaluate problematic smartphone use, the Headache Impact Test to measure the burden of headaches on daily life, the Neck Disability Index to assess functional limitations related to cervical spine disorders, the Hospital Anxiety and Depression Scale to screen for symptoms of anxiety and depression, the Jenkins Sleep Scale to evaluate sleep quality and disturbances, the 12-item Short Form Health Survey to assess physical and mental aspects of health-related quality of life, and the Visual Analog Scale to record the intensity of pain.

All assessments were performed face-to-face by trained professionals in a clinical setting. The study protocol was approved by the Clinical Research Ethics Committee. Written informed consent was obtained from each participant before enrollment, and all procedures were carried out in accordance with the principles of the Declaration of Helsinki.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-65 years
  • Literate and cognitively capable of completing questionnaires
  • Willing to participate and provide written informed consent
  • For the patient group: Diagnosis of cervicogenic headache based on the International Classification of Headache Disorders, third edition, confirmed by a neurologist
  • For the control group: Healthy volunteers with no known medical conditions or active complaints, age- and sex-matched with patients

排除标准

  • Comorbidities that may affect pain perception or mood, including diabetes mellitus, thyroid dysfunction, malignancy, chronic kidney disease, neurological diseases associated with neuropathic pain, rheumatoid arthritis, ankylosing spondylitis, or fibromyalgia
  • Illiteracy or impaired communication
  • Current use of medications that may interfere with outcome measures
  • Withdrawal of consent at any stage

结局指标

主要结局

Smartphone Addiction Scale - Short Form

时间窗: At baseline

Ten-item self-report questionnaire scored on a six-point Likert scale ranging from 1 to 6. The total score ranges from 10 to 60, with higher scores indicating a greater risk of smartphone addiction. Sex-specific cut-off values are 31 or higher for males and 33 or higher for females. A Turkish validated version is available.

次要结局

  • Headache Impact Test with 6 items(At baseline)
  • Neck Disability Index(At baseline)
  • Hospital Anxiety and Depression Scale(At baseline)
  • Jenkins Sleep Scale(At baseline)
  • Short Form-12 Health Survey(At baseline)

研究者

发起方
Gulseren Demir Karakilic
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gulseren Demir Karakilic

Assistant Professor, Principal Investigator

Bozok University

研究点 (1)

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