Effectiveness of Client-Centered Coping Skills Training in Migraine: A 6-Month Follow-Up, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period.
详细描述
Migraine is a significant public health issue characterized by frequently unilateral, recurrent, throbbing headaches. International Headache Disorders define migraine as a headache lasting 4-72 hours, accompanied by nausea, vomiting, phonophobia, or photophobia. Recurrent attacks can make it difficult to perform routine daily activities and movements. The World Health Organization lists migraine as one of the most disabling diseases. Approaches to treating migraine include pharmacological and non-pharmacological interventions. Non-pharmacological approaches aim to increase an individual's coping skills using exercise, stress management, and cognitive-behavioral therapy, which involve physical, mental, and cognitive interventions. While these approaches are practical individually, due to the impact of migraine on an individual's entire life, combined and client-centered approaches are needed.
Coping skills training (CST) has been shown to improve the physical and mental health and well-being of individuals with chronic headaches, significantly reducing pain intensity, migraine attacks, and medication use. It also aims to help individuals adapt to life more productively. Despite its positive effects, limited studies examine the impact of CST on individuals' coping skills and quality of life. A person-centered approach that combines various intervention components can enhance personal control and effectiveness in managing headaches. Due to the unpredictable timing of severe migraine attacks and the variable frequency of symptoms, client-centered coping skills training is recommended for managing migraines. Therefore, this study aimed to investigate the effects of client-centered coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine over a 6-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of migraine based on the International Classification of Headache Disorders (ICHD-3 beta) criteria,
- •age between 18 and 65 years,
排除标准
- •psychiatric disorders,
- •traumatic brain injury,
- •other types of headaches,
- •use of antidepressants, analgesics, anti-inflammatory drugs, or abusive substances (1 week before and during the treatments),
- •any additional treatment for migraine during the study period,
- •breastfeeding,
- •pregnancy.
研究组 & 干预措施
intervention group
CST aims to improve physical/mental health in chronic headache patients by reducing pain intensity, migraine attacks, and medication use. The program includes 8 sessions (2/week) covering:
Client-centered problem-solving & migraine education (COPM-based), Activity pacing, stress management, and healthy habits, Energy conservation techniques, Social participation, Program evaluation. Session durations: Session 1 (45 min), Sessions 2-6 (60-75 min), Sessions 7-8 (60 min).
干预措施: coping skills training (Behavioral)
control group
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: six months
Visual Analog Scale (VAS) is a pain intensity measurement scale. It consists of a horizontal line 10 cm in length. The participants were asked to indicate their average pain over the last month by drawing a line, placing a dot, or marking a point on this line. The value of 10 on the line's right side represents severe pain, while the value of 0 on the left side represents the absence of pain. This indicates that the maximum degree of pain is at the far right boundary, and the minimum is at the far left boundary. The length of the distance between the point the participants mark on the line and the point representing the absence of pain indicates the intensity of their pain. The internal consistency of the VAS scale has been found to be 0.82 .
次要结局
- Nottingham Health Profile (NHP)(six months)
- Migraine Disability Assessment Scale (MIDAS)(six months)
- Coping Orientation to Problems Experienced Inventory (Brief-COPE)(six months)
研究者
Etkin Bagi
Msc Occupational Therapist
Hacettepe University