]>
IRCT20250730066695N2 IRCT 2025-08-13 Hamedan University of Medical Sciences "The effect of diaphragmatic and resonance breathing techniques on arteriovenous fistula in hemodialysis patients" DRBT "The effects of diaphragmatic and resonance breathing techniques on physiological indices and pain intensity during arteriovenous fistula cannulation in hemodialysis patients” 2025-09-23 anticipated 135 Complete https://irct.ir/trial/85187 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Sampling will be done on a convenience basis, but the allocation of diaphragmatic breathing, resonant breathing, and cannulation control will be done using a 6-block randomization method as ABC-ACB-BCA-BAC-CAB-CBA. In this way, a sequence of the above blocks will be randomly generated using R software, and a list will be created, and patients will be randomly assigned to one of the three groups based on the aforementioned list, Blinding description: The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a single-blind study. N/A hemodialysis patients. Intervention 1: Intervention group 1: Diaphragmatic breathing technique for 5 minutes during three hemodialysis sessions. Intervention 2: Intervention group 2: Resonance breathing technique for 5 minutes during three hemodialysis sessions. Intervention 3: Control group: Control group: Routine hospital care. 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 Undecided - It is not yet known if there will be a plan to make this available
public Amir Hossein Asadi
Hamadan University of Medical Sciences, Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 1014 Amirasadi1977@gmail.com Hamedan University of Medical Sciences scientific Arezou Karampourian
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 1014 karampor1@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Having a history of hemodialysis through a fistula for at least three months, at least twice a week Being conscious Age 18 to 75 years No problems in accessing the vessels and no neuropathic disorders and peripheral vascular diseases No respiratory diseases (COPD, asthma, etc.) 18 years 75 years Both Life-threatening critical condition Unsuccessful cannulation on the first attempt Z49.02 Encounter for fitting and adjustment of peritoneal dialysis catheter Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Diaphragmatic breathing technique for 5 minutes during three hemodialysis sessions Intervention group 2: Resonance breathing technique for 5 minutes during three hemodialysis sessions. Control group: Control group: Routine hospital care The amount of pain felt by the patient is determined using the Numeric Rating Scale scale on a scale from 0 to 10. Timepoint: The intensity of patients' pain during the insertion of arterial and venous needles (in the two stages of cannulation) will be measured by an experienced dialysis nurse for all groups. Method of measurement: Assessment of patient pain from two cannulation lines using the Numeric Rating Scale by a nurse who is unaware of the study groups. Oxygen saturation percentage measured with a pulse oximeter. Timepoint: The measurement is performed in such a way that after the patient lies down on the bed and rests for 3 minutes, the oxygen saturation percentage will be measured. Method of measurement: Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups. Systolic blood pressure is the blood pressure during the contraction phase of the heart, which is recorded as a number in millimeters of mercury based on the monitoring device. Timepoint: The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, systolic blood pressure will be measured. Method of measurement: Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups. Diastolic blood pressure is the blood pressure during the resting phase of the heart, which is recorded as a number and in millimeters of mercury based on the monitoring device. Timepoint: The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, the diastolic blood pressure will be measured. Method of measurement: Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups. Mean atrial pressure= + (2 × diastolic pressure)] (systolic pressure)] / 3which is recorded as a number based on the monitoring device. Timepoint: The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, the Mean atrial pressure pressure will be measured. Method of measurement: Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups. The number of heartbeats per minute, which is monitored and recorded by a vital signs monitoring device. Timepoint: The measurement is performed in such a way that after the patient lies down on the bed and rests for 3 minutes, the number of heart beats per minute will be measured. Method of measurement: Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups. The number of breaths per minute, which is monitored and recorded by a vital signs monitoring device. Timepoint: The measurement is done in such a way that after the patient lies down on the bed and rests for 3 minutes, the number of breaths per minute will be measured. Method of measurement: Physiological indicators including oxygen saturation percentage, blood pressure (systolic, diastolic, Mean atrial pressure), heart rate, and respiratory rate will be recorded through a monitoring device by a nurse who is unaware of the study groups. Pain score. Timepoint: During cannulation. Method of measurement: Numeric Rating Scale. Mean systolic and diastolic blood pressure. Timepoint: 0, 1, 5 and 10 minutes after intervention. Method of measurement: Vital signs monitoring device. Pulse and respiration rate. Timepoint: 0, 1, 5 and 10 minutes after intervention. Method of measurement: Vital signs monitoring device. Hamedan University of Medical Sciences Approved 2025-07-26 Ethics committee of Hamadan University of Medical Sciences Ghaem Square, Shahid Fahmideh Street,Hamadan University of Medical Sciences Hamadan Hamadan Iran (Islamic Republic of)