Coping Skills Training in Individuals With Migraine

NCT ID: NCT05809375

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-07-31

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coping Skills Training Group

Coping skills training (CST) will be given to the intervention group in line with the goals of the International Headache Society. Of the participants included in this study, the ones in the intervention group will be evaluated before and after the intervention.

Group Type: ACTIVE_COMPARATOR

Coping Skills Training

Intervention Type: OTHER

In the intervention, it was acted in a way to include the educational content determined by the International Headache Association and with a problem-solving perspective. The coping skills training contents in the literature were combined, and the CST prepared by including the most used and related contents will be given. CST includes a targeted therapy specifically developed for this study to address the needs and expectations of individuals with migraine. The targeted CST was designed by the authors, consisting of an occupational therapist, and two physiotherapists with clinical, and academic experience. It is planned as a total of eight sessions, and two sessions per week. CST includes giving information about migraine, activity tempo, progressive muscle relaxation exercise, stress management, social participation, leisure time management, general evaluation of the program, and home program.

Control Grup

The participants in the control group will be evaluated at the beginning and after four weeks. CST will be given to the control group participants, if they want to, after the final evaluation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coping Skills Training

In the intervention, it was acted in a way to include the educational content determined by the International Headache Association and with a problem-solving perspective. The coping skills training contents in the literature were combined, and the CST prepared by including the most used and related contents will be given. CST includes a targeted therapy specifically developed for this study to address the needs and expectations of individuals with migraine. The targeted CST was designed by the authors, consisting of an occupational therapist, and two physiotherapists with clinical, and academic experience. It is planned as a total of eight sessions, and two sessions per week. CST includes giving information about migraine, activity tempo, progressive muscle relaxation exercise, stress management, social participation, leisure time management, general evaluation of the program, and home program.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Etkin Bagi

Msc Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamze Ekici

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Mahmut Yaran

Role: STUDY_CHAIR

Ondokuz Mayıs University

Central Contacts

Etkin BAĞCI

Role: CONTACT

etkinbag@gmail.com

+905067983965

Hacettepe University

Role: CONTACT

Other Identifiers

HU-ERG-EB-01

Identifier Type: -

Identifier Source: org_study_id