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IRCT20130218012509N6 IRCT 2021-08-13 Bagheiat-allah University of Medical Sciences The effect of non-pharmacological relaxation instructions on pain intensity, restlessness and delirium in mechanically ventilated patients after heart surgery The effect of non-pharmacological relaxation instructions on pain intensity, restlessness and delirium in mechanically ventilated patients after heart surgery 2021-07-06 anticipated 60 Complete https://irct.ir/trial/57126 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done in a simple way using a table of random numbers in such a way that the researcher first determines that all patients to whom the even number is assigned in group A (test) and those who become individual in group B (Control) are placed. Then close your eyes and put your finger on one of the digits in the table of random numbers and write down the house number and column number of the starting point. The direction of movement is predetermined and horizontally to the right, then It was at the top and then to the left of the table. Each even number is entered in the test group and the odd number is entered in the control group. Then all the numbers are placed in separate envelopes and all are placed in a box. When the sample with the entry conditions and easily entered the study, then the card removed from the box by the sample is opened for him and Depending on whether it has the letter A or B, the sample is placed in one of two test or control groups. In this way, sampling continues until reaching the specified sample size Found, Blinding description: In this study, blinding will be performed for patients participating in the trial. N/A Ischemic heart disease. Intervention 1: Intervention group: for the intervention group, a protocol designed including: informing patients by making changes in the environment, music with the content of nature sounds and the presence of family members on the patient's bed will be used. Intervention 2: Control group: Routine care will be provided for the control group. Yes - There is a plan to make this available What will be shared: All data obtained from the study can be published after identifying the participants in the study When: The access period starts 6 months after the results are published To whom: The data from this study will be available to researchers working in scientific and academic institutions Conditions: There are no special conditions Where to obtain: Contact email b.nehrir @bmsu.ac.ir How to obtain: Contact the email of the responsible author Comments:
public Batul Nehrir
Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences
Tehran Iran (Islamic Republic of) 7346181746 +98 21 8755 5576 pirnagmodin1364@yahoo.com Bagheiat-allah University of Medical Sciences scientific Batul Nehrir
Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences
Tehran Iran (Islamic Republic of) 7346181746 0217555576 rnehrir1739@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Ejection fraction at least 35% Surgery elective Lack of severe drug and alcohol addiction No delirium or impaired level of consciousness before surgery No severe visual or hearing impairment (blindness and deafness) Availability of first-degree family members or causal and relative relatives (at the patient's discretion) who wish to participate in the study 18 years 80 years Both Need for long-term mechanical ventilation as directed by your doctor Need for sedation according to the doctor according to the treatment process Unpredictable events (severe bleeding, severe hemodynamic disturbance, stroke) Death of research units during the study Reluctance and consent of the patient or family to continue participating in the study I25.0 Ischemic heart disease Lifestyle N/A Intervention group: for the intervention group, a protocol designed including: informing patients by making changes in the environment, music with the content of nature sounds and the presence of family members on the patient's bed will be used. Control group: Routine care will be provided for the control group. Pain Intensity. Timepoint: Before and after interventions. Method of measurement: Visual Analogue Scale. Agitation. Timepoint: Before and after interventions. Method of measurement: Richmond Agitation-Sedation Scale. Delirium. Timepoint: Before and after interventions. Method of measurement: Confusion Assessment Method for the ICU(CAM-ICU). Bagheiat-allah University of Medical Sciences Approved 2020-03-14 Ethics committee of Baqyatallah Medical Science University Sheikh Baha'i St. South, Baqiyatallah University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)