Coping Skills Training in Individuals With Migraine

NCT05809375 | Unknown

• 1 other identifier: HU-ERG-EB-01
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Keywords

Migraine; Pain; Coping Skills; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The patients are asked to rate the average pain perception they felt during the day in a 10 cm straight line. The beginning of the line means "0 = no pain," and the end of the line means "10 = maximal pain."

  four weeks

Secondary Outcomes (3)

• Nottingham Health Profile (NHP)

  four weeks

• Migraine Disability Assessment Score (MIDAS)

  four weeks

• The brief COPE

  four weeks

Study Arms (2)

Coping Skills Training Group

ACTIVE COMPARATOR

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.

Other: Coping Skills Training

Control Grup

NO INTERVENTION

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.

Interventions

Coping Skills Training 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.

Coping Skills Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Migraine Disorders; Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gamze Ekici

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Mahmut Yaran

  Ondokuz Mayıs University

  STUDY CHAIR

Central Study Contacts

Etkin BAĞCI

CONTACT

+905067983965; etkinbag@gmail.com

Hacettepe University

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an investigator who was blinded to group allocation. Coping Skills Training was given to the control group participants, if they wanted to, after the final evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Occupational Therapist

Model Details: This study was designed as an assessor-blind, randomized controlled, and parallel-group study.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 12, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share