TY - JOUR
T1 - Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine
T2 - A study protocol
AU - Renjith, Vishnu
AU - Pai, Aparna
AU - Radhakrishnan, Kurupath
AU - Nayak, Baby S.
AU - Devi, Elsa Sanatombi
AU - Ladd, Elissa
AU - George, Anice
N1 - Funding Information:
We thank Sigma Theta Tau International for funding this study. We thank Manipal University Press for the support in language editing of this manuscript.
Funding Information:
This research is funded by Sigma Theta Tau International/Omicron Delta Research Grants–June 2015
Publisher Copyright:
© 2017 John Wiley & Sons Ltd
PY - 2018/3/1
Y1 - 2018/3/1
N2 - 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.
AB - 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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U2 - 10.1111/jan.13478
DO - 10.1111/jan.13478
M3 - Article
AN - SCOPUS:85041679957
SN - 0309-2402
VL - 74
SP - 734
EP - 742
JO - Journal of Advanced Nursing
JF - Journal of Advanced Nursing
IS - 3
ER -