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IRCT20210525051405N1 IRCT 2021-09-15 The Iranian Center of Neurological Research The effect of Valsalva maneuver on migraine The effect of Valsalva maneuver on migraine 2020-09-22 anticipated 124 Complete https://irct.ir/trial/56537 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: A false Valsalva maneuver simulator is given to the control group to remove the Placebo effect without putting pressure on the individual, Randomization description: In this study, among the patients referred to the neurology clinic, migraine patients entered the intervention or control group based on random blocked method. The website named “Sealdenvelop.com” is used for this purpose. This site randomly divides the patients into groups of 4. The intervention group is given code A and the control group is given code B, and the groups are formed like ABBA, ABAB, BABA, etc. The examiner puts the patients in the order of enrollment in groups of four, and accordingly, each person is randomly given the code of the intervention group (A) or the code of the control group, Blinding description: patients in the study, are unaware of the classifying of the intervention or control group, and in explaining the use of the Valsalva maneuver simulator (true or false), they have been told that it might be effective on their headache. Therefore, they use it according to the instructions and mention its effect in the questionnaire. The Investigators who are in touch with the patients, track the use of devices, and gather information are unaware of the intervention and control group division; that is to say, they do not know coding A and B. The person who extracts the information and conducts the statistical analysis is unaware of the intervention and control group division and the meaning of coding. N/A Migraine. Intervention 1: Intervention group: To create the Valsalva maneuver, we have designed a device that is similar to the Valsalva maneuver. People exhale in this device, against a pressure of 40 mm Hg for 15 seconds and then normal breathing, experience all four phases of the Valsalva maneuver. They are asked to do this action in the acute phase headache for three times with five minutes intervals. They are also allowed to repeat this maneuver later in the chronic phase headache and register the data. Intervention 2: Control group: To counteract the placebo effect, people in this group are given a device similar to the intervention group, but in this device there is no pressure on the exhalation of people and they only do normal exhalation in this device, they do not experience any of the steps of Valsalva maneuver. . They are asked to perform this operation three times in the acute phase of the headache, five minutes apart. They are also allowed to repeat the maneuver later in the chronic phase of the headache and record the data. No - There is not a plan to make this available Justification or reason for not sharing IPD is To protect patients' personal information
public Kamran Shirbache
plate 3, alley 70, Bagh Daryache street, Isfahan
Isfahan Iran (Islamic Republic of) 817674461 +98 31 3786 8449 k-shirbache@alumnus.tums.ac.ir Tehran University of Medical Sciences scientific Mansoureh Togha
Unit 20, Floor 5, Iranian Doctors Building, Street No. 24, First Ghaem magham street, seventh of Tir square, Tehran
Tehran Iran (Islamic Republic of) 1586984447 +98 21 6694 0036 Toghae@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Migraine patients who have been diagnosed with migraine for more than one year Patients less than 50 years old. 18 years 65 years Both history of cerebrovascular aneurysm, history of recent brain surgery (less than 6 months), history of hemorrhagic stroke history of recent myocardial infarction (less than 6 months), history of heart failure and coronary artery disease history of syncope Uncontrolled hypertension, Systolic blood pressure less than 90 mm Hg and above 140 mm Hg retinopathy, Recent history of retinal surgery (less than 6 months), Intraocular lens implantation, history of cough induced headache Uncontrolled diabetes Aortic valve stenosis, Carotid artery stenosis G43 Migraine Treatment - Devices Treatment - Devices Intervention group: To create the Valsalva maneuver, we have designed a device that is similar to the Valsalva maneuver. People exhale in this device, against a pressure of 40 mm Hg for 15 seconds and then normal breathing, experience all four phases of the Valsalva maneuver. They are asked to do this action in the acute phase headache for three times with five minutes intervals. They are also allowed to repeat this maneuver later in the chronic phase headache and register the data. Control group: To counteract the placebo effect, people in this group are given a device similar to the intervention group, but in this device there is no pressure on the exhalation of people and they only do normal exhalation in this device, they do not experience any of the steps of Valsalva maneuver. . They are asked to perform this operation three times in the acute phase of the headache, five minutes apart. They are also allowed to repeat the maneuver later in the chronic phase of the headache and record the data. Score of headache in the questionnaire. Timepoint: before and after Valsalva maneuver. Method of measurement: Questionnaire and individual statement. Taking medicine. Timepoint: In acute and chronic phases of headache. Method of measurement: questionnaire and individual statement. Quality of life. Timepoint: Before and during the trial. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2020-11-21 Research Ethics Committees of Neuroscience Institute Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)