NCT06603493|Completed
Headaches: Effects on Sleep, Sensitization, and Psychological Factors
The Silent Saboteur: The Impact of Headaches on Sleep Disorders, Central Sensitization, Depression, Anxiety and Stress
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The Silent Saboteur: The Impact of Headaches on Sleep Disorders, Central Sensitization, Depression, Anxiety and Stress
Sponsor study identifier
observational
132
1 country
1
Study Start
September 19, 2024
Actual (reported)Primary Completion
November 19, 2024
Actual (reported)Study Completion
December 19, 2024
Actual (reported)Headache is one of the most common health problems in the society and negatively affects the quality of life of individuals. Increasing complaints of headache in recent years can be associated with many physiological and psychological factors. Sleep disturbances are one of these factors. Inadequate or non-restful sleep can interfere with the normal course of physical, mental, social and emotional functions. Impaired sleep quality interferes with the body\'s process of repairing and regenerating itself, which can lead to more serious health problems in the long term. Secondly, headaches can also lead to neurophysiological changes such as central sensitization. Central sensitization causes the nervous system to become hypersensitive, lowering the pain threshold and increasing pain perception. Finally, headache can have psychological effects by increasing levels of depression, anxiety and stress. This study aimed to determine the effects of headache on sleep disturbances, central sensitization, depression, anxiety and stress.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 19, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2024
Actual (reported)September 19, 2024
Actual (reported)September 19, 2024
Actual (reported)November 19, 2024
Actual (reported)December 19, 2024
Actual (reported)Assessment of sleep disorders
: Sleep disturbances were assessed with the Pittsburgh Sleep Quality Index (PSQI) . The PSQI is a 19-question questionnaire used to measure sleep habits over the past month and has 7 components. The total score ranges from 0 to 21, with higher scores indicating poor sleep quality. Scores of 5 and above are considered as sleep disturbance.
baseline
Assessment of depression, anxiety and stress levels
Depression, anxiety and stress levels were assessed using the Depression, Anxiety, Stress Scale (DASS-21). The DASS-21 consists of depression, anxiety and stress subscales, each with 7 questions. A maximum of 42 points can be obtained for each component (the first score is multiplied by two). Higher scores indicate the severity of the respective disorder. Cut-off values are different for each disorder: for depression, 0-9 (normal) to 28 and above (very severe), for anxiety 0-7 (normal) to 20 and above (very severe), and for stress 0-14 (normal) to 34 and above (very severe).
baseline
Assessment of Central Sensitization
Central sensitization was assessed with the Central Sensitization Inventory (SSI.) The SSE consists of 25 questions. The total score ranges from 0 to 100 and a score of 40 and above indicates the presence of central sensitization.
individuals diagnosed with migraine and tension-type headache according to the International Classification of Headache Disorders (International Classification of Headache Disorders, 3rd edition) will be placed in the headache group
Individuals aged 18-65 without headaches will be placed in control group.
: Sleep disturbances will be assessed with the Pittsburgh Sleep Quality Index
Central sensitization will be assessed with the Central Sensitization Inventory
Individuals aged 18-65 with and without headaches.
Atılım University
Ankara, Ankara, 06560, Turkey (Türkiye)
Sariçam, H., The psychometric properties of Turkish version of Depression Anxiety Stress Scale-21 (DASS-21) in health control and clinical samples. Journal of Cognitive Behavioral Psychotherapies and Research, 2018. 7(1): p. 19.
Lovibond, S.H., Manual for the depression anxiety stress scales. Sydney psychology foundation, 1995.
Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
132 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2024
First Posted
September 19, 2024
Study Start
September 19, 2024
Actual (reported)Effects of Multimodal Treatment of Headache in a Day Clinic Service
baseline
Depression, anxiety and stress levels will be assessed using the Depression, Anxiety, Stress Scale (DASS-21)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
Ağargün, M.Y., H. Kara, and Ö. Anlar, The validity and reliability of the Pittsburgh Sleep Quality Index. Turk Psikiyatri Derg, 1996. 7(2): p. 107-15.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Pambudi, P. and O. Sidabutar, Correlation between the Degree of Psychological Stress with Pain Intensity in Tension-Type Headache Patients. Jurnal Kedokteran Brawijaya, 2024: p. 6-10.
Suzuki K, Suzuki S, Shiina T, Kobayashi S, Hirata K. Central Sensitization in Migraine: A Narrative Review. J Pain Res. 2022 Sep 7;15:2673-2682. doi: 10.2147/JPR.S329280. eCollection 2022.
Sebastianelli G, Casillo F, Abagnale C, Renzo AD, Cioffi E, Parisi V, Lorenzo CD, Fazio F, Petricola F, Mattia C, Serrao M, Schoenen J, Coppola G. Central sensitization mechanisms in chronic migraine with medication overuse headache: a study of thalamocortical activation and lateral cortical inhibition. Cephalalgia. 2023 Oct;43(10):3331024231202240. doi: 10.1177/03331024231202240.
van Griensven H, Schmid A, Trendafilova T, Low M. Central Sensitization in Musculoskeletal Pain: Lost in Translation? J Orthop Sports Phys Ther. 2020 Nov;50(11):592-596. doi: 10.2519/jospt.2020.0610.
Karna B, Sankari A, Tatikonda G. Sleep Disorder. 2023 Jun 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560720/
Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2.
R P, S C N, S H, K R. Migraine Disability, Quality of Life, and Its Predictors. Ann Neurosci. 2020 Jan;27(1):18-23. doi: 10.1177/0972753120929563. Epub 2020 Jul 3.
Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: A review. Cephalalgia. 2016 Jan;36(1):67-91. doi: 10.1177/0333102415580099. Epub 2015 Apr 17.
Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
Primary Completion
November 19, 2024
Actual (reported)Study Completion
December 19, 2024
Actual (reported)Last Updated
November 25, 2025
Record last verified: 2025-11
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