Headache Disorders, PrimaryNCT05843760
Headache in Undergraduate Students and Biopsychosocial Status
An observational study of Headache Disorders, Primary and Prevalence, run by şeyda öztürk at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders, Primary, Prevalence, Migraine
- What is being tested?
- personal information form, headache-specific questionnaires and Questionnaires for assessing biopsychosocial status
- How many people
- 257 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2023to 12 Jun 2023
- How long will I take part?
- 3 Weeks
- 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: undergraduate students
Who may be able to join
- Having undergraduate education at Hacettepe University Faculty of Physical Therapy and Rehabilitation.
- be over 18 years old.
- To know Turkish.
- Volunteer to participate in the study.
Who cannot join
- Being over 65 years old.
- Having any neurological problem except headache.
- Any additional problems that prevent him from completing the questionnaires and scales.
- to be
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Prevalance of Headache and Effects on Biopsychosocial Status in Undergraduate Students
The primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants.
The second aim of this study is to examine the effects of headache on physical, social and psychological status in undergraduate student(participants) from a biopsychosocial perspective.
Read the detailed description
Headache is one of the most common nervous system disorders in society. 95 percent of the population has experienced a headache at least once in their life. The one-year prevalence is almost 1 in 2 people.
The prevalence of headache increases with age. While there is no difference between the sexes in terms of incidence before adolescence, it is more common in the female population in the post-adolescent period.
The ICF model, developed by the World Health Organization, adopts the biopsychosocial approach to provide a holistic perspective. According to this approach, it is aimed to develop interventions by evaluating and examining the biological and psychosocial effects of illness and disability, functionality, needs and demands of the individual.
Headache is also a disease that should be addressed from a biopsychosocial perspective.
Therefore, the primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants.
The second aim of this study is to examine the effects of headache on physical, social and psychological status in undergraduate student(participants) from a biopsychosocial perspective.
- Conditions
- Headache Disorders, Primary, Prevalence, Migraine, Student, Psychosocial Problem
- Being tested
- personal information form, headache-specific questionnaires, Questionnaires for assessing biopsychosocial status
- Keywords
- headache, biopsychosocial, migraine, psychosocial
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personal information formOther
undergraduate student(participants) will be asked; age, weight, height, smoking and alcohol use, and headache.
headache-specific questionnairesOther
ıd migraine test, numeric rate scale, hit-6 headache impact test, headache information form
Questionnaires for assessing biopsychosocial statusOther
hospital anxiety depression, Discomfort Intolerance Test, pittsburgh sleep quality index, fatigue severity scale, self compassion scale, Body Awareness Questionarre, cervical range of motion, İnternational Physical Activity Questionnaire, 12-Item Short-Form Health Survey
| Study group | Role | What they receive |
|---|---|---|
| undergraduate students | Hacettepe University Faculty of Physical Therapy and Rehabilitation undergraduate students Receives: Other: personal information form; Other: headache-specific questionnaires; Other: Questionnaires for assessing biopsychosocial status |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevelance
Headache prevalence in undergraduate students
Measured: april 2023-may 2023
Secondary outcomes (14)
effect of headache on biopsychosocial status
Sleep Quality- Pittsburgh Sleep Quality Index- A minimum of 0 and a maximum of 21 points can be obtained from this scale. The higher the score, the worse the sleep quality.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Anxiety Depression Level- Hospital Anxiety Depression Scale- A minimum of 0 and a maximum of 42 points can be obtained from this scale. The higher the score, the higher the severity of anxiety depression.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Personal Information Form- In this form, participants' height, weight, age, gender, smoking and alcohol use, whether they have a headache or not, and their education level are questioned. there is no minimum or maximum value
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Self Compassion- Self Compassion Scale- A minimum of 24 and a maximum of 130 points can be obtained from this scale. The higher the score, the higher the level of self-compassion.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Fatigue Level- The Fatigue Severity Scale - A minimum of 0 and a maximum of 9 points can be obtained from this scale. The higher the score, the higher the severity of fatigue.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Body Awareness- Body Awareness Scale- A minimum of 18 and a maximum of 126 points can be obtained from this scale. The higher the score, the higher the body awareness.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Physical Activity Level- International Physical Activity Questionnaire - The scale score is defined in 3 different categories as a result of the scores obtained in the range of minimum 0 and maximum +3000 points. As the score obtained from the scale increases, the level of physical activity increases. results are reported in categories. (low activity levels, moderate activity levels, or high activity levels).
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Cervical Range of Motion- The participant is asked to evaluate the cervical joint range of motion in 6 directions (flexion, extension, right/left lateral flexion, and right/left rotation). The minimum score is 0, the maximum score is 10. The higher the score, the higher the range of motion.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Quality of Life-Short Form-12 (SF-12) - The total score ranges from 0-100. The higher the score, the higher the quality of life.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Discomfort intolerance level- Discomfort Intolerance Scale- The total score changes from a minimum of 0 to a maximum of 42 points. As the total scores of the participants increase, it is accepted that the tolerance to the discomfort is higher.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Numeric Rate Scale- A minimum of 0 and a maximum of 10 points is obtained from the scale. A high score indicates a high headache.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
ID- MIGRAINE TEST-There are 3 questions in this test. It is stated that the participants who answer yes to two of the questions are more likely to have migraine.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
Headache Impact Test (HIT-6™)- A minimum of 36 points and a maximum of 78 points are taken from this scale. The higher the total score obtained from the questionnaire, the worse the quality of life of the participants with headaches.
Measured: april 2023-may 2023
effect of headache on biopsychosocial status
In this form, participants with headaches are asked about the severity of the pain, the frequency, location and duration of the pain, whether there is a family history of headaches, etc.
Measured: april 2023-may 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start4 May 2023
- Primary completion2 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, PrimaryStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 257 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- şeyda öztürk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, şeyda öztürk, Hacettepe University
- Investigators
- nezire köse, prof, Study director, HacettepeUniversity Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843760
- Sponsor's protocol ID
- Hacettepe univercity
- Status last verified
- Sep 2023
- First submitted
- 14 Apr 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
PubMed 17381554Bellini B, Arruda M, Cescut A, Saulle C, Persico A, Carotenuto M, Gatta M, Nacinovich R, Piazza FP, Termine C, Tozzi E, Lucchese F, Guidetti V. Headache and comorbidity in children and adolescents. J Headache Pain. 2013 Sep 24;14(1):79. doi: 10.1186/1129-2377-14-79.
PubMed 24063537Baxter P. ICF: health vs disease. Dev Med Child Neurol. 2004 May;46(5):291. doi: 10.1017/s0012162204000477. No abstract available.
PubMed 15132257
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Prevalance of Headache and Effects on Biopsychosocial Status in Undergraduate Students
- ClinicalTrials.gov ID
- NCT05843760
- Acronym / sponsor ID
- Hacettepe univercity
- Conditions
- Headache Disorders, Primary, Prevalence, Migraine, Student, Psychosocial Problem
- Keywords
- headache, biopsychosocial, migraine, psychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- şeyda öztürkUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 6 May 2023 (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.
The primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants.
The second aim of this study is to examine the effects of headache on physical, social and psychological status in undergraduate student(participants) from a biopsychosocial perspective.
Detailed description
Headache is one of the most common nervous system disorders in society. 95 percent of the population has experienced a headache at least once in their life. The one-year prevalence is almost 1 in 2 people.
The prevalence of headache increases with age. While there is no difference between the sexes in terms of incidence before adolescence, it is more common in the female population in the post-adolescent period.
The ICF model, developed by the World Health Organization, adopts the biopsychosocial approach to provide a holistic perspective. According to this approach, it is aimed to develop interventions by evaluating and examining the biological and psychosocial effects of illness and disability, functionality, needs and demands of the individual.
Headache is also a disease that should be addressed from a biopsychosocial perspective.
Therefore, the primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants.
The second aim of this study is to examine the effects of headache on physical, social and psychological status in undergraduate student(participants) from a biopsychosocial perspective.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| undergraduate students | – | Other: personal information form, Other: headache-specific questionnaires, Other: Questionnaires for assessing biopsychosocial statusHacettepe University Faculty of Physical Therapy and Rehabilitation undergraduate students |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- undergraduate students
Key inclusion criteria (4 listed)
- Having undergraduate education at Hacettepe University Faculty of Physical Therapy and Rehabilitation.
- be over 18 years old.
- To know Turkish.
- Volunteer to participate in the study.
Key exclusion criteria (4 listed)
- Being over 65 years old.
- Having any neurological problem except headache.
- Any additional problems that prevent him from completing the questionnaires and scales.
- to be
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personal information formundergraduate student(participants) will be asked; age, weight, height, smoking and alcohol use, and headache. | Other | undergraduate students |
| headache-specific questionnairesıd migraine test, numeric rate scale, hit-6 headache impact test, headache information form | Other | undergraduate students |
| Questionnaires for assessing biopsychosocial statushospital anxiety depression, Discomfort Intolerance Test, pittsburgh sleep quality index, fatigue severity scale, self compassion scale, Body Awareness Questionarre, cervical range of motion, İnternational Physical Activity Questionnaire, 12-Item Short-Form Health Survey | Other | undergraduate students |
Primary outcome
prevelance
Time frame: april 2023-may 2023
Headache prevalence in undergraduate students
14 secondary outcomes
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
effect of headache on biopsychosocial status
Time frame: april 2023-may 2023
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 3 Oct 2023.
- Background: PubMed 17381554Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.
- Background: PubMed 24063537Bellini B, Arruda M, Cescut A, Saulle C, Persico A, Carotenuto M, Gatta M, Nacinovich R, Piazza FP, Termine C, Tozzi E, Lucchese F, Guidetti V. Headache and comorbidity in children and adolescents. J Headache Pain. 2013 Sep 24;14(1):79. doi: 10.1186/1129-2377-14-79.
- Background: PubMed 15132257Baxter P. ICF: health vs disease. Dev Med Child Neurol. 2004 May;46(5):291. doi: 10.1017/s0012162204000477. No abstract available.
- The global burden of headache: a documentation of headache prevalence and disability worldwideLink provided by the sponsor.
- Headache and comorbidity in children and adolescentsLink provided by the sponsor.
- ICF: health vs diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
nezire köse, prof study director
HacettepeUniversity Faculty of Physical Therapy and Rehabilitation
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 Headache Disorders, Primary and Prevalence, run by şeyda öztürk 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 4 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 3 Oct 2023. 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?
prevelance (time frame: april 2023-may 2023). 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 NCT05843760, which also lists 3 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 3 Oct 2023.