- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292129
Smartphone Addiction in Cervicogenic Headache
Smartphone Addiction as a Modifiable Factor in Cervicogenic Headache: Effects on Pain, Function, Mood, and Sleep
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yozgat
-
Yozgat, Yozgat, Turkey (Türkiye), 66100
- Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cervicogenic Headache Group
Adults between 18 and 65 years of age diagnosed with cervicogenic headache based on the International Classification of Headache Disorders, third edition were eligible for inclusion.
Exclusion criteria included systemic diseases such as diabetes mellitus, thyroid disorders, chronic kidney disease, malignancy, neurological conditions associated with neuropathic pain, and rheumatic diseases including rheumatoid arthritis, ankylosing spondylitis, or fibromyalgia.
Participants with communication difficulties, illiteracy, or those who declined participation were also excluded.
|
|
Healthy Control Group
Age- and sex-matched adults without cervicogenic headache or other chronic medical conditions served as controls.
Controls were between 18 and 65 years of age, cognitively intact, literate, and willing to participate.
Exclusion criteria were the same as for the cervicogenic headache group, including systemic, neurological, or rheumatological diseases, illiteracy, or refusal to participate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smartphone Addiction Scale - Short Form
Time Frame: 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.
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Impact Test with 6 items
Time Frame: At baseline
|
Patient-reported questionnaire assessing the impact of headache on pain, vitality, role limitations, and emotional function.
Each of the six items is scored from 6 to 13, producing a total score between 36 and 78.
Higher scores indicate a greater negative impact of headache.
A Turkish validated version is available.
|
At baseline
|
|
Neck Disability Index
Time Frame: At baseline
|
Self-reported questionnaire with ten items scored from 0 to 5. The total score is converted into a percentage ranging from 0 to 100 percent.
Higher percentages indicate greater disability related to neck pain.
A Turkish validated version is available.
|
At baseline
|
|
Hospital Anxiety and Depression Scale
Time Frame: At baseline
|
Fourteen-item questionnaire with two subscales assessing anxiety and depression, each scored from 0 to 21.
Higher scores indicate more severe symptoms.
Cut-off scores are defined as 0 to 7 for normal, 8 to 10 for mild, 11 to 14 for moderate, and 15 to 21 for severe symptoms.
A Turkish validated version is available.
|
At baseline
|
|
Jenkins Sleep Scale
Time Frame: At baseline
|
Four-item questionnaire assessing sleep quality and sleep disturbances.
The total score ranges from 0 to 20, with higher scores indicating poorer sleep quality.
A score greater than 15 indicates clinically relevant poor sleep.
A Turkish validated version is available.
|
At baseline
|
|
Short Form-12 Health Survey
Time Frame: At baseline
|
Twelve-item questionnaire assessing physical and mental components of health-related quality of life.
It provides physical and mental component scores scaled from 0 to 100, with higher scores indicating better perceived quality of life.
A Turkish validated version is available
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülseren Demir Karakılıç, Yozgat Bozok University
Publications and helpful links
General Publications
- Telci EA, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagli N. The cultural adaptation, reliability, and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1732-5. doi: 10.1097/BRS.0b013e3181ac9055.
- Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
- Dikmen PY, Bozdag M, Gunes M, Kosak S, Tasdelen B, Uluduz D, Ozge A. Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine. Noro Psikiyatr Ars. 2020 Apr 24;58(4):300-307. doi: 10.29399/npa.24956. eCollection 2021.
- Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.
- NOYAN, C.O., et al., Akıllı Telefon Bağımlılığı Ölçeğinin Kısa Formunun üniversite öğrencilerindeTürkçe geçerlilik ve güvenilirlik çalışması. Anatolian Journal of Psychiatry/Anadolu Psikiyatri Dergisi, 2015. 16.
- Duruoz MT, Erdem D, Gencer K, Ulutatar F, Baklacioglu HS. Validity and reliability of the Turkish version of the Jenkins Sleep Scale in psoriatic arthritis. Rheumatol Int. 2018 Feb;38(2):261-265. doi: 10.1007/s00296-017-3911-2. Epub 2017 Dec 18.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Technology Addiction
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Headache Disorders
- Sleep Wake Disorders
- Behavior, Addictive
- Compulsive Behavior
- Impulsive Behavior
- Headache Disorders, Secondary
- Behavior
- Internet Addiction Disorder
- Anxiety Disorders
- Parasomnias
- Depression
- Post-Traumatic Headache
Other Study ID Numbers
- 2025-GOKAEK-2512_2025.06.18_50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervicogenic Headache
-
Meltem UzunCompletedExercise | Therapeutics | Headache, CervicogenicTurkey
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosCompletedCervicogenic HeadachesUnited States
-
Des Moines UniversityCompleted
-
Hungarian University of Sports ScienceCairo UniversityCompleted
-
Foundation University IslamabadRecruiting
-
Cairo UniversityNot yet recruiting
-
University of LahoreCompletedCervicogenic HeadachePakistan
-
Istanbul Medipol University HospitalIstanbul Kent UniversityCompletedCervicogenic Headache | Cervicogenic HeadachesTurkey (Türkiye)
-
Ankara City Hospital BilkentRecruitingCervicogenic Headache | Third Occipital NerveTurkey (Türkiye)
-
Hong Kong Baptist UniversityActive, not recruiting