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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Determining effects of breathing techniques on migraine like headaches frequency and intensity with "migraine disability assessment " (MIDAS) questionnaire.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
breathing techniques
The patients in the intervention group will be taught and practiced breathing technique. Breathing techniques will be taught face-to-face by the researcher to the patients in the intervention group. The participant will breathe through one nostril at a natural rate and depth, while the other nostril will be closed with the thumb or forefinger. After the act of breathing, it will open the closed nostril, close the open nostril and breathe naturally. As explained later, they will continue the cycle with the act of breathing. This process is described as a loop.
Intervention: breathing techniques (Behavioral)
treatment as usual
The control group will continue his/her usual treatment as advised by the physician.
Outcomes
Primary Outcomes
Determining effects of breathing techniques on migraine like headaches frequency and intensity with "migraine disability assessment " (MIDAS) questionnaire.
Time Frame: Three months
The MIDAS is a self-administered tool to assess migraine-related disability over the previous 3 months . The questionnaire comprises seven questions in total. Three questions assess the number of missed days due to headache. Two questions assess the number of additional days with limited productivity. The total MIDAS score is the sum of the days given as response to these five questions. The total score ranges from 0 to 90 and is used to categorize patients in disability grades I to IV. A higher score means more severe disability.Two additional questions measure headache frequency and average pain intensity. Frequency is noted as the number of days in the previous 3 months on which the patient experienced migraine. Intensity is noted as the average pain intensity of these episodes on a scale of 1-10. These two items are not taken into account when estimating the total MIDAS score.
Secondary Outcomes
- Determining effects of breathing techniques to "migraine disability assessment " (MIDAS) scores of migraine patients.(Three months)
Investigators
Oğulcan Çöme
Principal Investigator
Dokuz Eylul University