Clinical trial NCT05536635: Effect of Breathing Techniques on Migraine Attacks and Severity
Official title: The Effect of Breathing Techniques on Attack Frequency and Severity in Migraine-like Headaches-randomised Control Trial: Study Protocol for a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headaches
Breathing Techniques
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background:

Migraine is a very common neurobiological disorder caused by increased excitability of the Central Nervous System. It is among the causes of the highest morbidity worldwide. Migraine has considerable economic and social impact ; affects the quality of life of patients and disrupts work life, social activities and family life. To decrease the frequency and severity of migraine attacks may be the first goal than treating the attacks.

The study was designed as a Parallel Group, Add on, Randomized Controlled Experiment in order to observe the effects of breathing techniques on migraine-like headaches, frequency and severity.

Methods:

Participants will be divided into 2 parallel arms, intervention and control (treatment as usual). Cluster randomization will be performed to prevent intergroup contamination. Breathing techniques will be taught to the intervention group by the researcher. Both groups will continue to use pharmacotherapy for migraine. Both groups will be evaluated with migraine disability level (MIDAS) at the beginning and end of the study. The primary output of the study is to evaluate the effect of breathing techniques on the frequency and severity of attacks in migraine-like headaches. The secondary output is to evaluate the effect of breathing techniques on the MIDAS level.

Discussion:

The results of the study will provide information about the effect of breathing techniques on migraine-like headaches. The results of this study will contribute to the literature, since migraine is among the chronic diseases and pharmacotherapy options are limited.


Eligibility criteria: Inclusion Criteria:

* Are 18-50 Age
* Have a computer and/or smart phone
* Have an internet connection that can be used at home and at work (with a computer or smart phone)
* Are volunteer to participate in the research
* Have Frequency of attacks less than 3 months
* Fulfil diagnostic criteria of migraine like headaches

Exclusion Criteria:

* Severe anatomical defect in the airway
* Pregnancy
* Having any diagnosed psychiatric disease
* Using psychiatric medication
* Having speech and hearing problems
* Having any chronic disease which may be worsening by taking deep breath

Primary outcomes:
measure: Determining effects of breathing techniques on migraine like headaches frequency and intensity with "migraine disability assessment " (MIDAS) questionnaire.
timeFrame: Three months
Secondary outcomes:
measure: Determining effects of breathing techniques to "migraine disability assessment " (MIDAS) scores of migraine patients.
timeFrame: Three months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine
Study officials:
affiliation: Dokuz Eylul University Medical School
name: ogulcan D come, MD
role: PRINCIPAL_INVESTIGATOR
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