NCT07292129

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

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

June 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 5, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

Headache ImpactNeck DisabilityAnxiety and DepressionSleep DisturbanceQuality of LifeSmartphone Use

Outcome Measures

Primary Outcomes (1)

  • Smartphone Addiction Scale - Short Form

    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 Outcomes (5)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with cervicogenic headache according to the International Classification of Headache Disorders, third edition, confirmed by a neurologist, were recruited from the outpatient clinics of the Departments of Physical Medicine and Rehabilitation and Neurology at Yozgat Bozok University. Age- and sex-matched healthy volunteers were recruited from the same community.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 35730511BACKGROUND
  • 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.

    BACKGROUND
  • Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.

    BACKGROUND
  • 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.

    PMID: 19770615BACKGROUND
  • 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.

    PMID: 34924791BACKGROUND
  • 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.

MeSH Terms

Conditions

Post-Traumatic HeadacheInternet Addiction DisorderAnxiety DisordersDepressionParasomnias

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTechnology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorMental DisordersBehavioral SymptomsSleep Wake Disorders

Study Officials

  • Gülseren Demir Karakılıç

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

June 19, 2025

Primary Completion

October 3, 2025

Study Completion

October 3, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data collected for this study, including questionnaire scores and demographic variables, will be available upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The datasets will be available beginning 6 months after publication of the study results and will remain accessible for 5 years thereafter.
Access Criteria
Researchers who provide a methodologically sound proposal may request access to the de-identified datasets. Data will be shared after approval of the proposal and signing of a data access agreement. Requests should be directed to the corresponding author via the institutional email address.
More information

Locations