Protocol summary
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Study aim
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Determination nature music effect on Delirium incidence in post Coronary Artery Bypass Graft (CABG) surgery patients.
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Design
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Randomized trial, parallel with control group, two blind sides design for 100 patients, using blocking for randomization
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Settings and conduct
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This study will take place in Isfahan Milad hospital'sI Intensive Care Unit (ICU). After admission of patients in the ICU and extubation, they will test by Confusion Assessment Method-ICU (CAM-ICU) and if the result is negative and the whisper test is positive, they will enter the study. In order to blinding, a medical student will do the CAM-ICU test two times a day and the intervention will take place by an ICU nurse. the nurse will play the one hour music with a headphone two times a day for 2 days.
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Participants/Inclusion and exclusion criteria
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Patients who are post Coronary Artery Bypass Graft (CABG) and assent to participation and age less than 75 will enter to our study; if they have any history of psychological disorders, cerebrovascular accident or hepatic or renal failure, history of any drug and alcohol abuse, who have prescribed special drugs which can cause delirium in operation room or Intensive Care Unit (ICU) and special condition which can cause central nervous system hypoxemia in operation room, patients who have positive delirium test after operation room, can not enter the study.
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Intervention groups
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Samples divide randomly in intervention and control groups; We play two one hour music sessions each day for 2 days by a headphone. In control group we don't play any music.
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Main outcome variables
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Delirium incidence will measure by Confusion Assesment Method-Intensive Care Unit (CAM-ICU) test; Changes in Richmond Agitation Sedation Scale (RASS) score mean after and befor intervention; ICU hospitalization time mean; Vital signs and Atrial Blood Gas parameters means in both groups.
General information
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Reason for update
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Data collection have been finished.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200608047693N1
Registration date:
2020-06-23, 1399/04/03
Registration timing:
prospective
Last update:
2021-07-02, 1400/04/11
Update count:
1
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Registration date
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2020-06-23, 1399/04/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2021-08-23, 1400/06/01
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Actual recruitment start date
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2020-10-26, 1399/08/05
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Actual recruitment end date
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2021-06-20, 1400/03/30
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Trial completion date
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2021-06-20, 1400/03/30
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Scientific title
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Study of nature music effect on Delirium incidence in post Coronary Artery Bypass Graft (CABG) surgery patients a controlled randomized clinical trial
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Public title
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Effect of nature sound on consciousness after open Heart surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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To 74 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-09, 1399/02/20
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Ethics committee reference number
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IR.MUI.MED.REC.1399.115
Health conditions studied
1
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Description of health condition studied
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Post CABG delirium
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ICD-10 code
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F05
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ICD-10 code description
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Delirium due to known physiological condition
Primary outcomes
1
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Description
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Delirium incidence according to CAM-ICU test result
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Timepoint
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Checking delirium CAM-ICU test before intervention and at 3 and 9 p.m. daily
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Method of measurement
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Confusion Assessment Method for the Intensive Care Unite score
Secondary outcomes
1
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Description
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RASS core mean before and after intervention
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Timepoint
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Before intervention and at 3 and 9 p.m. dailykl
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Method of measurement
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Richmond agitation and sedation scale
2
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Description
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Difference in ICU hospitalization mean time in both groups
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Timepoint
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At the end of ICU hospitalization
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Method of measurement
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ICU hospitalization hours
3
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Description
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Difference in vital signs mean between two groups
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Timepoint
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In period of 3 p.m. to 8 p.m. and 9 p.m. to 2 p.m.
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Method of measurement
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Heart rate, respiratory rate and blood pressure
4
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Description
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Difference in ABG parameters means in both groups
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Timepoint
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In period of 3 p.m. to 8 p.m. and 9 p.m. to 2 p.m.
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Method of measurement
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Chemical results for pco2( partial pressure of carbon dioxide), po2 (partial pressure of oxygen), ph( potential hydrogen) and base excess
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: In this group we only will check their vital signs, blood gases and Confusion Assessment Method-Intensive Care Unit test.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available