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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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History
# Registration date Revision Id
2 2021-07-01, 1400/04/10 188688
1 2020-06-23, 1399/04/03 140246
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  • General information

    empty
    100
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    2020-10-26, 1399/08/05
    empty
    2021-06-20, 1400/03/30
    empty
    2021-06-20, 1400/03/30
    empty
    Data collection have been finished.
    empty
    جمع آوری اطلاعات به پایان رسیده است.
    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 less than 28% hematocrit during caridopulmonary pomping.
    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
    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
    افرادی که سابقه سکته مغزی دارند
    افرادی که برای آنها در اتاق عمل از داروی کتامین یا میدازولام استفاده شده است یا در گزارش پرستاری ذکر شود که در آی سی یو بنزودیازپین ها ، هالوپریدول و پروپوفول دریافت کرده است
    افرادی که طبق گزارش عمل در طی جراحی دچار میانگین فشار پرفیوژنحین پمپ کمتر از 70 میلی‌مترجیوه پیدا میکنند
    افرادی که طبق گزارش عمل در طی جراحی مدت کلامپ بیشتر از 88 دقیقه داشته اند
    افرادی که طبق گزارش عمل در طی جراحی مدت پمپ قلبی- ریوی بیشتر از 142 دقیقه داشته اند
    افرادی که طبق گزارش عمل حین پمپ قلبی – ریوی در طی جراحی هماتوکریت کمتر از 28 % پیدا میکنند
    افرادی که طبق گزارش عمل جراحی در حین عمل به جراحی دیگری نیاز پیدا کنند
    افراد اعتیاد به مواد مخدر دارند
    افرادی که پس از اتاق عمل تست بررسی گیجی در آی سی یو مثبت داشته باشند
    افرادی که سابقه سیروز کبدی یا نارسایی کلیوی دارند
    افرادی که داروهای روانگردان یا آنتی‌سایکوتیک مصرف میکنند
    افرادی که الکلیسم هستند
    افراد که سابقه افسردگی جدی که دارو مصرف کنند و مشکلات روانپزشکی که با پرسشنامه افسردگی بک مشخص میشوند را دارند
    افرادی که سابقه دمانس قبلی دارند
    افرادی که سابقه سکته مغزی دارند
    افرادی که برای آنها در اتاق عمل از داروی کتامین یا میدازولام استفاده شده است یا در گزارش پرستاری ذکر شود که در آی سی یو بنزودیازپین ها ، هالوپریدول و پروپوفول دریافت کرده است
    افرادی که طبق گزارش عمل در طی جراحی دچار میانگین فشار پرفیوژنحین پمپ کمتر از 70 میلی‌مترجیوه پیدا میکنند
    افرادی که طبق گزارش عمل در طی جراحی مدت کلامپ بیشتر از 88 دقیقه داشته اند
    افرادی که طبق گزارش عمل در طی جراحی مدت پمپ قلبی- ریوی بیشتر از 142 دقیقه داشته اند
    افرادی که طبق گزارش عمل جراحی در حین عمل به جراحی دیگری نیاز پیدا کنند
    افراد اعتیاد به مواد مخدر دارند
    افرادی که پس از اتاق عمل تست بررسی گیجی در آی سی یو مثبت داشته باشند
    افرادی که سابقه سیروز کبدی یا نارسایی کلیوی دارند
    افرادی که داروهای روانگردان یا آنتی‌سایکوتیک مصرف میکنند
    افرادی که الکلیسم هستند
    افراد که سابقه افسردگی جدی که دارو مصرف کنند و مشکلات روانپزشکی که با پرسشنامه افسردگی بک مشخص میشوند را دارند
    افرادی که سابقه دمانس قبلی دارند

  • Recruitment centers

    #1
    Name of recruitment center - English: Milad hospital
    Name of recruitment center - Persian: بیمارستان میلاد
    Full name of responsible person - English: Fatemeh Esfahanian
    Full name of responsible person - Persian: فاطمه لصفهانیان
    Street address - English: Bakhshi St, Janbazan St., Keshavarz Blvd
    Street address - Persian: بلوار کشاورز، خیابان جانبازان، خیابان بخشی، بیمارستان میلاد
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 31 3777 4003
    Fax:
    Email: miladhospital.esf@yahoo.com
    Web page address:
    Name of recruitment center - English: Milad hospital
    Name of recruitment center - Persian: بیمارستان میلاد
    Full name of responsible person - English: Fatemeh Esfahanian
    Full name of responsible person - Persian: فاطمه اصفهانیان
    Street address - English: Bakhshi St, Janbazan St., Keshavarz Blvd
    Street address - Persian: بلوار کشاورز، خیابان جانبازان، خیابان بخشی، بیمارستان میلاد
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 31 3777 4003
    Fax:
    Email: miladhospital.esf@yahoo.com
    Web page address:

Protocol summary

Study aim
Determination nature music effect on Delirium incidence in post Coronary Artery Bypass Graft (CABG) surgery patients.
Design
Randomized trial, parallel with control group, two blind sides design for 100 patients, using blocking for randomization
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
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

Reason for update
Data collection have been finished.
Acronym
IRCT registration information
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
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Fatemeh Esfahanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2733
Email address
fatemeh.esfahanian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
2020-10-26, 1399/08/05
Actual recruitment end date
2021-06-20, 1400/03/30
Trial completion date
2021-06-20, 1400/03/30
Scientific title
Study of nature music effect on Delirium incidence in post Coronary Artery Bypass Graft (CABG) surgery patients a controlled randomized clinical trial
Public title
Effect of nature sound on consciousness after open Heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
To 74 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences., Hezarjarib St., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.MUI.MED.REC.1399.115

Health conditions studied

1

Description of health condition studied
Post CABG delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

2

Description
Difference in ICU hospitalization mean time in both groups
Timepoint
At the end of ICU hospitalization
Method of measurement
ICU hospitalization hours

3

Description
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

4

Description
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

Intervention groups

1

Description
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.
Category
Prevention

2

Description
Control group: In this group we only will check their vital signs, blood gases and Confusion Assessment Method-Intensive Care Unit test.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Fatemeh Esfahanian
Street address
Bakhshi St, Janbazan St., Keshavarz Blvd
City
Isfahan
Province
Isfehan
Postal code
0000000000
Phone
+98 31 3777 4003
Email
miladhospital.esf@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
N. 4, Isfahan university oh medical science, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Esfahanian
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kamal 5 All., Goli All., Besheti St
City
Kashan
Province
Isfehan
Postal code
8715115663
Phone
+98 31 5554 2733
Email
fatemeh.esfahanian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Mirmohammadsadeghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zarrin Build., Qasr Cross., Shamsabadi St
City
Isfahan
Province
Isfehan
Postal code
000000000
Phone
+98 31 3236 6620
Email
mirmohammadsadeghi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Esfahanian
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kamal 5 All., Goli All., Besheti St
City
Kashan
Province
Isfehan
Postal code
8715115663
Phone
+98 31 5554 2733
Email
fatemeh.esfahanian@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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