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IRCT20200608047693N1 IRCT 2020-06-23 Esfahan University of Medical Sciences Effect of nature sound on consciousness after open Heart surgery Study of nature music effect on Delirium incidence in post Coronary Artery Bypass Graft (CABG) surgery patients a controlled randomized clinical trial 2020-06-21 anticipated 100 Complete https://irct.ir/trial/48720 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to randomize our samples we use random sequence (Blocking) by Excel; We use 4 blocks to equal two groups for entrance the study. Blocks are chosen from samples and fall in group A or B by Excel; In the end we will decide one the groups to be the control and the intervention, Blinding description: In order to blind the study we choose different person from ICU nurses to perform the intervention; The main researcher who will do the finale test will be different and cant contact the nurses. Our data analyzer will not informed about the patients groups and finally the patients will have information about their groups. 3 Post CABG delirium. Intervention 1: Intervention group: We play 9 tracks of nature sound which their names areA Deer in the distance by Stuart Jones ، Cool Forest Rain ، A calming cadence ، Driftwood ، Calm the mind ، Spirit wind و Ankgor Wat by Dan Gibson ، joyful tweet by Serenity Nature Sounds Academy و Rock of Ages by Steve Wingfield at 2 and 8 p.m. The tracks will be playes by a headphone with 10% volume, low tempo( 60-80 bpm) and 440-470 KHz frequency. Before intervention and after each music sessions we will do Confusion Assessment Method-Intensive Care Unit and meanwhile we will check vital signs and blood gas. Intervention 2: Control group: In this group we only will check their vital signs, blood gases and Confusion Assessment Method-Intensive Care Unit test. 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 The data are not completed yet.
public Fatemeh Esfahanian
Kamal 5 All., Goli All., Besheti St
Kashan Iran (Islamic Republic of) 8715115663 +98 31 5554 2733 fatemeh.esfahanian@gmail.com Esfahan University of Medical Sciences scientific Mohsen Mirmohammadsadeghi
Zarrin Build., Qasr Cross., Shamsabadi St
Isfahan Iran (Islamic Republic of) 000000000 +98 31 3236 6620 mirmohammadsadeghi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Post CABG patients Patients who assent to participation in the study Patients who their auditory status are confirmed by Whisper test Patients under 75 years old no limit 74 years Both Patients with history of CVA Patients who have prescribed Ketamine or Midazolam in operation room or Benzodiazepine , Hallopridol or Propofol in ICU Patients who have mean perfusion pressure less than 70 mmHg during operation Patients who have more than 88 minutes clamp time Patients who have more than 142 minutes cardiopulmonary pomp during operation Patients who have second operation during CABG according to operation report Patients who have drug addiction Patients who have positive CAM-ICU after operation room Patients who have history of renal failure or cirrhosis Patients with anti-psychotic or psychedelic drugs history Patients who are alcoholism Patients with Major Depression disorder who have acceptable Beck Depression Inventory score Patients with history of Dementia F05 Delirium due to known physiological condition Prevention N/A Intervention group: We play 9 tracks of nature sound which their names areA Deer in the distance by Stuart Jones ، Cool Forest Rain ، A calming cadence ، Driftwood ، Calm the mind ، Spirit wind و Ankgor Wat by Dan Gibson ، joyful tweet by Serenity Nature Sounds Academy و Rock of Ages by Steve Wingfield at 2 and 8 p.m. The tracks will be playes by a headphone with 10% volume, low tempo( 60-80 bpm) and 440-470 KHz frequency. Before intervention and after each music sessions we will do Confusion Assessment Method-Intensive Care Unit and meanwhile we will check vital signs and blood gas. Control group: In this group we only will check their vital signs, blood gases and Confusion Assessment Method-Intensive Care Unit test. Delirium incidence according to CAM-ICU test result. Timepoint: Checking delirium CAM-ICU test before intervention and at 3 and 9 p.m. daily. Method of measurement: Confusion Assessment Method for the Intensive Care Unite score. RASS core mean before and after intervention. Timepoint: Before intervention and at 3 and 9 p.m. dailykl. Method of measurement: Richmond agitation and sedation scale. Difference in ICU hospitalization mean time in both groups. Timepoint: At the end of ICU hospitalization. Method of measurement: ICU hospitalization hours. Difference in vital signs mean between two groups. Timepoint: In period of 3 p.m. to 8 p.m. and 9 p.m. to 2 p.m. Method of measurement: Heart rate, respiratory rate and blood pressure. Difference in ABG parameters means in both groups. Timepoint: In period of 3 p.m. to 8 p.m. and 9 p.m. to 2 p.m. Method of measurement: Chemical results for pco2( partial pressure of carbon dioxide), po2 (partial pressure of oxygen), ph( potential hydrogen) and base excess. Esfahan University of Medical Sciences Approved 2020-05-09 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical sciences., Hezarjarib St., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)