Clinical trial NCT05809375: Coping Skills Training in Individuals With Migraine
Official title: Investigation of the Effects of a Client-centered Coping Skills Training in Individuals With Migraine: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Keywords: Migraine
Pain
Coping Skills
Quality of Life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as an assessor-blind, randomized controlled, and parallel-group study.
Primary purpose: TREATMENT

Brief summary: This study was planned to investigate the effects of coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine.

Detailed description: Migraine is a type of headache that lasts 4-72 hours, and it is characterized by throbbing pain on one side of the head, and recurrent attacks, making routine daily activities and movements difficult. Also, nausea and vomiting may accompany migraine, and sensitivity to both light and sound may increase. The World Health Organization (WHO) lists migraine as the disease that causes the most disability.

Approaches to the treatment of migraine consist of pharmacological and non-pharmacological treatments. Within the scope of non-pharmacological approaches, it is aimed to increase the coping skills of the individual by using methods such as exercise, stress management, and cognitive behavioral therapy, which include physical, mental, and cognitive interventions. Although these approaches are effective respectively, since migraine affects the whole life of the individual, there is a need for applications in which the approaches are applied with a combined and individual perspective. It has been shown that coping skills training improves both the physical and mental health and well-being of individuals with chronic headaches. It is known to cause a decrease in pain intensity, migraine attacks, and drug use. At the same time, it is aimed to adapt the individual to live efficiently. Despite these positive effects, there is a limited number of studies examining the effect of migraine coping skills training on individuals' disabilities and coping skills. Therefore, within the scope of this study, the effects of client-centered coping skills training on pain, disability, coping skills, and quality of life were examined.

Eligibility criteria: Inclusion Criteria:

* have a diagnosis of migraine meeting the International Headache Society diagnostic criteria (ICHD-3 beta International Classification of Headache Disorders),
* to be between the ages of 18-65,
* to have a migraine onset age younger than 50 (migraine onset age shouldn't be 50 years or more because being above is usually a secondary reason)
* to be literate.

Exclusion Criteria:

* have psychotic disorders, organic brain damage, other types of headaches, a history of traumatic head injuries, neck pain, any pathology causing headaches in the head and neck,
* alcohol or substance use,
* pregnancy

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: four weeks
Secondary outcomes:
measure: Nottingham Health Profile (NHP)
timeFrame: four weeks
measure: Migraine Disability Assessment Score (MIDAS)
timeFrame: four weeks
measure: The brief COPE
timeFrame: four weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Gamze Ekici
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University
name: Mahmut Yaran
role: STUDY_CHAIR
References: