Effect of Breathing Techniques on Migraine Attacks and Severity

Migraine Headaches Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536635
• Other study ID #: 7201
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2022
• Source: Dokuz Eylul University
• Contact: ogulcan come, MD
• Phone: 00905398612323
• Email: ogulcan.come[@]deu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: July 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headaches
• Respiratory Aspiration

Intervention

Behavioral:
• breathing techniques
Intervention will be daily use of breathing techniques thought by the researcher as explained in detail in arm/group descriptions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

References & Publications (14)

Bennett MH, French C, Schnabel A, Wasiak J, Kranke P. Normobaric and hyperbaric oxygen therapy for migraine and cluster headache. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005219. doi: 10.1002/14651858.CD005219.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD005219. — View Citation

Bernardi L, Spadacini G, Bellwon J, Hajric R, Roskamm H, Frey AW. Effect of breathing rate on oxygen saturation and exercise performance in chronic heart failure. Lancet. 1998 May 2;351(9112):1308-11. — View Citation

Bilo G, Revera M, Bussotti M, Bonacina D, Styczkiewicz K, Caldara G, Giglio A, Faini A, Giuliano A, Lombardi C, Kawecka-Jaszcz K, Mancia G, Agostoni P, Parati G. Effects of slow deep breathing at high altitude on oxygen saturation, pulmonary and systemic hemodynamics. PLoS One. 2012;7(11):e49074. doi: 10.1371/journal.pone.0049074. Epub 2012 Nov 12. — View Citation

Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies. Headache. 2018 Apr;58(4):496-505. doi: 10.1111/head.13281. Epub 2018 Mar 12. — View Citation

Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007 Jan 15;26(1):2-19. — View Citation

Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. — View Citation

Ciarambino T, Sansone G, Menna G, Para O, Signoriello G, Leoncini L, Giordano M. Oxygen Therapy in Headache Disorders: A Systematic Review. Brain Sci. 2021 Mar 17;11(3). pii: 379. doi: 10.3390/brainsci11030379. — View Citation

Matera DV, Smith B, Lam B. Revisiting the expanded use of hyperbaric oxygen therapy for treatment of resistant migraines. Med Gas Res. 2019 Oct-Dec;9(4):238-240. doi: 10.4103/2045-9912.273963. — View Citation

Moher D, Jones A, Lepage L; CONSORT Group (Consolidated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001 Apr 18;285(15):1992-5. — View Citation

Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials. 2005;2(2):152-62. — View Citation

Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817. — View Citation

Silberstein SD. Migraine. Lancet. 2004 Jan 31;363(9406):381-91. Review. — View Citation

Singhal AB, Maas MB, Goldstein JN, Mills BB, Chen DW, Ayata C, Kacmarek RM, Topcuoglu MA. High-flow oxygen therapy for treatment of acute migraine: A randomized crossover trial. Cephalalgia. 2017 Jul;37(8):730-736. doi: 10.1177/0333102416651453. Epub 2016 May 20. — View Citation

Spatenkova V, Bednar R, Oravcova G, Melichova A, Kuriscak E. Yogic breathing in hypobaric environment: breathing exercising and its effect on hypobaric hypoxemia and heart rate at 3,650-m elevation. J Exerc Rehabil. 2021 Aug 23;17(4):270-278. doi: 10.12965/jer.2142324.162. eCollection 2021 Aug. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining effects of breathing techniques on migraine like headaches frequency and intensity with "migraine disability assessment " (MIDAS) questionnaire.	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.	Three months
Secondary	Determining effects of breathing techniques to "migraine disability assessment " (MIDAS) scores of migraine patients.	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.	Three months