Migraine headaches are the 3rd most common medical problem in the world with a global prevalence of 14.7%. Migraine is associated with substantial impairment in disability and was ranked as the seventh highest cause of disability globally (Lipton et al. 2016, Vos et al. 2013, Steiner et al. 2013). Conventional management of migraine headache is suboptimal, and overuse of episodic medication will lead to the development of chronic daily headache. The trial was primarily designed to investigate the effectiveness of a multicomponent intervention in reducing disability of patients with migraine. The study was underpinned by the framework of the Health Belief Model (HBM).
Methods:
The study was a prospective, randomized, controlled, single-blinded pragmatic trial with parallel arms. The trial was designed based on International Headache Society’s guidelines for controlled trials in migraine. Participants were randomized to intervention (n=40) and control arms (n=40). The participants randomized to the intervention arm received the multicomponent intervention. The multicomponent intervention included behavioral-lifestyle modification and sessions on pranayama (a form of yoga breathing exercise). The behavioral-lifestyle modification focussed on five areas of migraine management. Three pranayamas which were selected for the intervention programme were Seetali Pranayama, Nadishodhana Pranayama, and Bhrahmari Pranayama.The participants in the control arm received routine care. The subjects were then followed up, and the outcomes were assessed at 4th, 12th and 24th week. Disability of the migraineurs was assessed using the Headache Impact Test (HIT). HIT is a six-item scale used to measure the impact headaches can have on the ability to function on the job, at school, at home, and in social situations. The total scores range from 36-78, with higher scores indicating greater disability (Kosinski, 2003). Copyright permission was obtained to use the scale.
Results:
Majority of the participants were in the age group of 18-30 years. There was a preponderance of female participants in the study with 82.5% of subjects being females in intervention and control arm. The family history of migraine was present in 80% of participants in the intervention arm and 70% in control arm. The mean (SD) pre-test disability scores of intervention and control arms were 70.50 (4.05) and 71.80 (3.03) respectively. Repeated Measures Analysis of Variance (RM ANOVA) was used for analyzing the intervention effect at multiple time points. Intention To Treat (ITT) approach was the primary analytic approach to data analysis. The multicomponent intervention had a statistically significant effect on disability scores of patients with migraine [Interaction effects- F (2.36,184.48) = 50.18, p < 0.001]. Patients in the intervention arm demonstrated significant reductions in disability scores. The effect sizes were large, indicating a high clinical significance for the intervention.
Conclusion:
Subjects in the intervention arm demonstrated statistically significant reductions in migraine-related disability. Similar interventions have demonstrated reductions in migraine-related disability (Dindo et al. 2013, Friedman et al. 2012, Smith et al. 2010). The empirical evidence generated from this experiment has the potential for informing decision-making in areas of clinical practice, education, policy, and research. The research demonstrated the multicomponent had a positive impact on disability of patients with migraine. The importance of intervention as shown by this research should be considered for use by nursing professionals working in neurological settings.