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Effect of Breathing Techniques on Migraine Attacks and Severity

Primary Purpose

Migraine Headaches, Breathing Techniques

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
breathing techniques
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Headaches

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    breathing techniques

    treatment as usual

    Arm Description

    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.

    The control group will continue his/her usual treatment as advised by the physician.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 6, 2022
    Last Updated
    September 9, 2022
    Sponsor
    Dokuz Eylul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05536635
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dokuz Eylul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Headaches, Breathing Techniques

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    breathing techniques
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    treatment as usual
    Arm Type
    No Intervention
    Arm Description
    The control group will continue his/her usual treatment as advised by the physician.
    Intervention Type
    Behavioral
    Intervention Name(s)
    breathing techniques
    Intervention Description
    Intervention will be daily use of breathing techniques thought by the researcher as explained in detail in arm/group descriptions
    Primary Outcome Measure Information:
    Title
    Determining effects of breathing techniques on migraine like headaches frequency and intensity with "migraine disability assessment " (MIDAS) questionnaire.
    Description
    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.
    Time Frame
    Three months
    Secondary Outcome Measure Information:
    Title
    Determining effects of breathing techniques to "migraine disability assessment " (MIDAS) scores of migraine patients.
    Description
    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.
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ogulcan come, MD
    Phone
    00905398612323
    Email
    ogulcan.come@deu.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    azize dilek guldal, proff
    Phone
    +905322944377
    Email
    guldal.dilek@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ogulcan D come, MD
    Organizational Affiliation
    Dokuz Eylul University Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effect of Breathing Techniques on Migraine Attacks and Severity

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