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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05843760
Other study ID # Hacettepe univercity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 4, 2023
Est. completion date June 12, 2023

Study information

Verified date September 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 257
Est. completion date June 12, 2023
Est. primary completion date June 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Intervention

Other:
personal information form
undergraduate student(participants) will be asked; age, weight, height, smoking and alcohol use, and headache.
headache-specific questionnaires
id migraine test, numeric rate scale, hit-6 headache impact test, headache information form
Questionnaires for assessing biopsychosocial status
hospital anxiety depression, Discomfort Intolerance Test, pittsburgh sleep quality index, fatigue severity scale, self compassion scale, Body Awareness Questionarre, cervical range of motion, International Physical Activity Questionnaire, 12-Item Short-Form Health Survey

Locations

Country Name City State
Turkey Hacettepe Univercity Ankara

Sponsors (1)

Lead Sponsor Collaborator
seyda öztürk

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Baxter P. ICF: health vs disease. Dev Med Child Neurol. 2004 May;46(5):291. doi: 10.1017/s0012162204000477. No abstract available. — View Citation

Bellini 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary prevelance Headache prevalence in undergraduate students april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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 april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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). april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
Secondary 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. april 2023-may 2023
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