Migraine HeadachesNCT05536635

Effect of Breathing Techniques on Migraine Attacks and Severity

A study testing breathing techniques in people with Migraine Headaches and Breathing Techniques, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Migraine Headaches, Breathing Techniques
What is being tested?: breathing techniques
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Nov 2022to 1 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Dokuz Eylul University Faculty of Medicine
Izmir

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions: Migraine Headaches, Breathing Techniques
Being tested: breathing techniques
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05536635
Study group	Role	What they receive
breathing techniques	Experimental	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. Receives: Behavioral: breathing techniques
treatment as usual	No intervention	The control group will continue his/her usual treatment as advised by the physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Three months

Secondary outcomes (1)

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.
Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20221 Nov 2023

First posted13 Sep 2022
Study start1 Nov 2022
Primary completion1 Jun 2023
Study completion1 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Migraine HeadachesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05536635
Sponsor's protocol ID: 7201
Status last verified: Sep 2024
First submitted: 6 Sep 2022
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Silberstein SD. Migraine. Lancet. 2004 Jan 31;363(9406):381-91. doi: 10.1016/S0140-6736(04)15440-8.
PubMed 15070571
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.
PubMed 29527677
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):379. doi: 10.3390/brainsci11030379.
PubMed 33802647
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.
PubMed 18646121
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.
PubMed 27206964
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.
PubMed 31898611
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. doi: 10.1016/S0140-6736(97)10341-5.
PubMed 9643792
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.
PubMed 23152851
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.
PubMed 29209423
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.
PubMed 34527639
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. doi: 10.1001/jama.285.15.1992.
PubMed 11308436
Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.
PubMed 15031246
Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007 Jan 15;26(1):2-19. doi: 10.1002/sim.2731.
PubMed 17136746
Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials. 2005;2(2):152-62. doi: 10.1191/1740774505cn076oa.
PubMed 16279137

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine Headaches trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05536635
Acronym / sponsor ID: 7201
Conditions: Migraine Headaches, Breathing Techniques
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Dokuz Eylul UniversityUniversity, hospital or other
Study start: 1 Nov 2022 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Nov 2023 (actual)
First posted: 13 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

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:

Discussion:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
breathing techniques	Experimental	Behavioral: breathing techniquesThe 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.
treatment as usual	No intervention	–The control group will continue his/her usual treatment as advised by the physician.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

Severe anatomical defect in the airway
Pregnancy
Having any diagnosed psychiatric disease
Using psychiatric medication
Having speech and hearing problems

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
breathing techniquesIntervention will be daily use of breathing techniques thought by the researcher as explained in detail in arm/group descriptions	Behavioural	breathing techniques

Primary outcome

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.

1 secondary outcome

Determining effects of breathing techniques to "migraine disability assessment " (MIDAS) scores of migraine patients.
Time frame: Three months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Background: PubMed 15070571Silberstein SD. Migraine. Lancet. 2004 Jan 31;363(9406):381-91. doi: 10.1016/S0140-6736(04)15440-8.
Background: PubMed 29527677Burch 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.
Background: PubMed 33802647Ciarambino 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):379. doi: 10.3390/brainsci11030379.
Background: PubMed 18646121Bennett 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.
Background: PubMed 27206964Singhal 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.
Background: PubMed 31898611Matera 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.
Background: PubMed 9643792Bernardi 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. doi: 10.1016/S0140-6736(97)10341-5.
Background: PubMed 23152851Bilo 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.
Background: PubMed 29209423Russo 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.
Background: PubMed 34527639Spatenkova 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.
Background: PubMed 11308436Moher 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. doi: 10.1001/jama.285.15.1992.
Background: PubMed 15031246Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ogulcan D come, MD principal investigator

Dokuz Eylul University Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing breathing techniques in people with Migraine Headaches and Breathing Techniques, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determining effects of breathing techniques on migraine like headaches frequency and intensity with "migraine disability assessment " (MIDAS) questionnaire. (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536635, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.