Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine

A study protocol

Vishnu Renjith, Aparna Pai, Kurupath Radhakrishnan, Baby S. Nayak, Elsa Sanatombi Devi, Elissa Ladd, Anice George

Research output: Contribution to journalArticle

Abstract

Aim: To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Background: Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). Design: The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. Methods: The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Discussion: Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. Trial Registration: The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in,). CTRI reference ID: CTRI/2015/10/006282.

Original languageEnglish
Pages (from-to)734-742
Number of pages9
JournalJournal of Advanced Nursing
Volume74
Issue number3
DOIs
Publication statusPublished - 01-03-2018

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Migraine Disorders
Randomized Controlled Trials
Registries
India
Clinical Trials
Quality of Life
Breathing Exercises
Play Therapy
Aptitude
Clinical Protocols
Life Style
Primary Health Care
Sleep
Eating
Delivery of Health Care
Pain
Therapeutics

All Science Journal Classification (ASJC) codes

  • Nursing(all)

Cite this

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abstract = "Aim: To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Background: Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). Design: The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. Methods: The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Discussion: Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. Trial Registration: The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in,). CTRI reference ID: CTRI/2015/10/006282.",
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Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine : A study protocol. / Renjith, Vishnu; Pai, Aparna; Radhakrishnan, Kurupath; Nayak, Baby S.; Devi, Elsa Sanatombi; Ladd, Elissa; George, Anice.

In: Journal of Advanced Nursing, Vol. 74, No. 3, 01.03.2018, p. 734-742.

Research output: Contribution to journalArticle

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