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IRCT20250607066101N1 IRCT 2025-06-15 Khomein School of Medical Sciences Investigation of the effect of Buteyko breathing technique on sleep quality, fatigue, and Peripheral blood oxygen saturation in patients with acute coronary syndrome(ACS) Investigation of the effect of Buteyko breathing technique on sleep quality, fatigue, and Peripheral blood oxygen saturation in patients with acute coronary syndrome(ACS) 2025-07-23 anticipated 92 Complete https://irct.ir/trial/84197 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization and allocation of participants will be performed by an independent researcher using a list of patients and selection via artificial intelligence (Chatbot), Blinding description: The blinding procedure in this study is implemented as a triple-blind design. Participants are completely unaware of their allocation to either the intervention or control group. The interventionists, who are responsible for teaching and administering the breathing techniques, have no knowledge of the patients’ group assignments. Randomization is carried out by an independent researcher using artificial intelligence software, ensuring that the interventionists deliver the assigned interventions without any information about group allocation. Data assessors, who collect questionnaires and perform physiological measurements such as peripheral oxygen saturation (SpO2), are also blinded to the type of intervention each patient receives and operate independently from the intervention team. The statistical analyst responsible for data analysis is likewise blinded to the group assignments to prevent any bias during interpretation of the results. Random allocation is performed by an independent supervisor, and coded labels are assigned to each group; these codes remain concealed until the completion of the study and all data analyses. The breathing technique trainings are provided to both groups in a standardized and visually identical manner, preventing participants and hospital staff from discerning any differences between groups. This rigorous blinding approach minimizes biases arising from the awareness of participants, interventionists, and assessors, thereby enhancing the internal validity and reliability of the study findings. N/A Acute Coronary Syndrome. Intervention 1: Intervention group: On the first day, for patients with acute coronary syndrome in the hospital, once their physical and mental conditions stabilize, education is provided by the intervention team regarding the nature of acute coronary syndrome and its symptoms and complications. Then, on the same day, the intervention group is taught the Buteyko breathing technique by the intervention team. Patients are then asked to perform the breathing technique in the presence of the intervention team so that the researcher can correct any errors. Additionally, pamphlets related to the Buteyko breathing technique and an educational audio file of BBT narrated by the primary researcher are given to the intervention group. Group A also receives their usual therapeutic and care treatments.The method of performing the Buteyko breathing technique is described as follows:Step 1: Controlled Pause PhaseThe patient sits upright and breathes normally through the nose with the mouth closed for 30 seconds.Then, a small inhalation and exhalation are performed.After exhalation, the patient pinches the nose to prevent air from entering (lungs are almost empty).The patient counts the time until the first urge to breathe in (this time is called the "controlled pause").Then the nose is released, and the patient breathes in, but the next breath should not be deeper than before.The goal of this phase is to reduce hyperventilation and increase tolerance to carbon dioxide.Step 2: Shallow BreathingThe patient sits upright and feels the airflow from the nostrils with a finger placed under them.Breathing should be calm and shallow, without pressure or deep breaths.Repetition of StepsThese two steps are alternated and performed for about 20 minutes.Then, patients in Group A (intervention) are asked to practice the designed Buteyko breathing technique (BBT) for 6 weeks at times when they are at the hospital and at home. Each patient should practice intensively for 20 minutes, 5 days a week. The session time should be at least two hours after breakfast in the morning. Each patient is asked to perform this technique at home twice a day (morning and evening, at least 2 hours after eating) during the study period. However, on the first day of hospitalization, due to patient fatigue from admission, they are asked to perform the breathing technique only once, and the intervention duration on the first day is reduced to 10 minutes. Intervention 2: Control group: Group B (control group) learns the diaphragmatic breathing technique from the intervention team and also receives their usual therapeutic and care treatments from the medical staff. They are asked to perform this technique as long as they are hospitalized. Patients in both groups are followed up weekly by phone during the intervention period by the intervention team, who are blinded to the group assignments. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Marziyeh Mousivand
Qods Street
khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 marzie.mosivand@khomeinums.ac.ir Khomein School of Medical Sciences scientific Mehdi Safarabadi
Qods Street
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of acute coronary syndrome by a cardiologist Age ≥ 30 of the participants BMI < 35 SPO2>90% 30 years no limit Both No diagnosis of heart failure in the study subject No history of specific diseases: individuals with a history of respiratory diseases such as asthma, COPD, bronchitis, etc., or heart surgery within the past two months. Absence of cardiac dysrhythmia in the study subject No history of mental illness, because psychological problems can affect the patient's ability to participate in the intervention. No cognitive impairments affecting the ability to learn and perform breathing techniques No history of myocardial infarction in the past two weeks No use of any other breathing or relaxation techniques in the intervention and control groups to prevent cross-effects of other interventions. Non-smoking No diagnosis of rheumatoid arthritis Participants who develop serious complications, such as uncontrolled cardiac disorders, requiring exclusion from the study to prevent harm to them. Participants' unwillingness to continue the study for any reason Feeling discomfort while performing the Buteyko breathing technique I24.9 Acute ischemic heart disease, unspecified Rehabilitation N/A Intervention group: On the first day, for patients with acute coronary syndrome in the hospital, once their physical and mental conditions stabilize, education is provided by the intervention team regarding the nature of acute coronary syndrome and its symptoms and complications. Then, on the same day, the intervention group is taught the Buteyko breathing technique by the intervention team. Patients are then asked to perform the breathing technique in the presence of the intervention team so that the researcher can correct any errors. Additionally, pamphlets related to the Buteyko breathing technique and an educational audio file of BBT narrated by the primary researcher are given to the intervention group. Group A also receives their usual therapeutic and care treatments.The method of performing the Buteyko breathing technique is described as follows:Step 1: Controlled Pause PhaseThe patient sits upright and breathes normally through the nose with the mouth closed for 30 seconds.Then, a small inhalation and exhalation are performed.After exhalation, the patient pinches the nose to prevent air from entering (lungs are almost empty).The patient counts the time until the first urge to breathe in (this time is called the "controlled pause").Then the nose is released, and the patient breathes in, but the next breath should not be deeper than before.The goal of this phase is to reduce hyperventilation and increase tolerance to carbon dioxide.Step 2: Shallow BreathingThe patient sits upright and feels the airflow from the nostrils with a finger placed under them.Breathing should be calm and shallow, without pressure or deep breaths.Repetition of StepsThese two steps are alternated and performed for about 20 minutes.Then, patients in Group A (intervention) are asked to practice the designed Buteyko breathing technique (BBT) for 6 weeks at times when they are at the hospital and at home. Each patient should practice intensively for 20 minutes, 5 days a week. The session time should be at least two hours after breakfast in the morning. Each patient is asked to perform this technique at home twice a day (morning and evening, at least 2 hours after eating) during the study period. However, on the first day of hospitalization, due to patient fatigue from admission, they are asked to perform the breathing technique only once, and the intervention duration on the first day is reduced to 10 minutes. Control group: Group B (control group) learns the diaphragmatic breathing technique from the intervention team and also receives their usual therapeutic and care treatments from the medical staff. They are asked to perform this technique as long as they are hospitalized. Patients in both groups are followed up weekly by phone during the intervention period by the intervention team, who are blinded to the group assignments. Pittsburgh Sleep Quality Index Score. Timepoint: At the beginning of the study, 7, 14, 21, 28, 35, 42. Method of measurement: Pittsburgh Sleep Quality Index. Fatigue Score of the Multidimensional Fatigue Inventory. Timepoint: At the beginning of the study, 7, 14, 21, 28, 35, 42. Method of measurement: Multidimensional Fatigue Inventory. Peripheral Oxygen Saturation. Timepoint: 1 day after the first implementation of the intervention. Method of measurement: Pulse Oximeter. Khomein School of Medical Sciences Approved 2025-06-11 Ethics committee of Khomein University of Medical Sciences Zeynab-e-Kobra Hospital, next to Health Network, Ghods Boulevard, after 9th Dey Square, Arak-Khomein Road Khomein Markazi Iran (Islamic Republic of)