Cervicogenic HeadacheNCT07292129
Smartphone Addiction in Cervicogenic Headache
An observational study of Cervicogenic Headache and Smartphone Addiction, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache, Smartphone Addiction
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2025to 3 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, 66100
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cervicogenic Headache, Smartphone Addiction
- Keywords
- Headache Impact, Neck Disability, Anxiety and Depression, Sleep Disturbance, Quality of Life, Smartphone Use
- Medical subject headings
- Post-Traumatic Headache, Internet Addiction Disorder, Anxiety Disorders, Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (5)
Headache Impact Test with 6 items
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.
Measured: At baseline
Neck Disability Index
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.
Measured: At baseline
Hospital Anxiety and Depression Scale
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.
Measured: At baseline
Jenkins Sleep Scale
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.
Measured: At baseline
Short Form-12 Health Survey
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start19 Jun 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulseren Demir Karakilic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulseren Demir Karakilic, Bozok University
- Investigators
- Gülseren Demir Karakılıç, Principal investigator, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292129
- Sponsor's protocol ID
- 2025-GOKAEK-2512_2025.06.18_50
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected for this study, including questionnaire scores and demographic variables, will be available upon reasonable request.
Publications
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.
PubMed 35730511NOYAN, 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.
Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.
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.
PubMed 19770615Dikmen 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.
PubMed 34924791Duruoz 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.
PubMed 29250729
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Addiction as a Modifiable Factor in Cervicogenic Headache: Effects on Pain, Function, Mood, and Sleep
- ClinicalTrials.gov ID
- NCT07292129
- Acronym / sponsor ID
- 2025-GOKAEK-2512_2025.06.18_50
- Conditions
- Cervicogenic Headache, Smartphone Addiction
- Keywords
- Headache Impact, Neck Disability, Anxiety and Depression, Sleep Disturbance, Quality of Life, Smartphone Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Gulseren Demir KarakilicUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Headache Impact Test with 6 items
Time frame: At baseline
Neck Disability Index
Time frame: At baseline
Hospital Anxiety and Depression Scale
Time frame: At baseline
Jenkins Sleep Scale
Time frame: At baseline
Short Form-12 Health Survey
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 35730511Soylu 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.
- BackgroundNOYAN, 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.
- BackgroundAydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.
- Background: PubMed 19770615Telci 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.
- Background: PubMed 34924791Dikmen 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.
- Results publication: PubMed 29250729Duruoz 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected for this study, including questionnaire scores and demographic variables, will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülseren Demir Karakılıç principal investigator
Yozgat Bozok University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervicogenic Headache and Smartphone Addiction, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smartphone Addiction Scale - Short Form (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07292129, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.