Effect of Breathing Techniques on Migraine Attacks and Severity

September 15, 2024 updated by: Oğulcan Çöme, Dokuz Eylul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Dokuz Eylul University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: breathing techniques
Intervention will be daily use of breathing techniques thought by the researcher as explained in detail in arm/group descriptions
No Intervention: treatment as usual
The control group will continue his/her usual treatment as advised by the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining effects of breathing techniques to "migraine disability assessment " (MIDAS) scores of migraine patients.
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.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Principal Investigator: ogulcan D come, MD, Dokuz Eylul University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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