Headaches: Effects on Sleep, Sensitization, and Psychological Factors

NCT06603493 | Completed

• 1 other identifier: Atılım Physiotherapy
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache Disorder

Keywords

Headache; sleep; Central Nervous System Sensitization; Depression; Anxiety; Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline

Study Arms (2)

Headache Group

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

Other: Assessment of sleep disorders; Other: Assessment of Central Sensitization; Other: Assessment of depression, anxiety and stress levels

Control Group

Individuals aged 18-65 without headaches will be placed in control group.

Other: Assessment of sleep disorders; Other: Assessment of Central Sensitization; Other: Assessment of depression, anxiety and stress levels

Interventions

Assessment of sleep disorders OTHER

: Sleep disturbances will be assessed with the Pittsburgh Sleep Quality Index

Control Group; Headache Group

Assessment of Central Sensitization OTHER

Central sensitization will be assessed with the Central Sensitization Inventory

Control Group; Headache Group

Assessment of depression, anxiety and stress levels OTHER

Depression, anxiety and stress levels will be assessed using the Depression, Anxiety, Stress Scale (DASS-21)

Control Group; Headache Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 18-65 with and without headaches.

You may qualify if:

• being 18-65 years who agreed to participate

You may not qualify if:

• Neurological disorders
• Musculoskeletal diseases
• Chronic pain conditions
• Psychiatric diseases

Sponsors & Collaborators

• Nagihan Acet: lead

Study Sites (1)

Atılım University

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  RESULT

• Lovibond, S.H., Manual for the depression anxiety stress scales. Sydney psychology foundation, 1995.

  RESULT

• 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.

  PMID: 21951710 RESULT

• 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.

  PMID: 35382371 RESULT

• 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.

  RESULT

• 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.

  PMID: 2748771 RESULT

• 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.

  RESULT

• 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.

  PMID: 36101891 RESULT

• 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.

  PMID: 37795647 RESULT

• 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.

  PMID: 33131390 RESULT

• Karna B, Sankari A, Tatikonda G. Sleep Disorder. 2023 Jun 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560720/

  PMID: 32809555 RESULT

• 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.

  PMID: 35410119 RESULT

• 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.

  PMID: 32982095 RESULT

• 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.

  PMID: 25888584 RESULT

• 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.

  PMID: 20473702 RESULT

MeSH Terms

Conditions

Headache Disorders; Headache; Depression; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 19, 2024
• Primary Completion: November 19, 2024
• Study Completion: December 19, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

TU (1)