Protocol summary

Summary
The purpose of this study was to investigate the effect of education using Multi¬Media on postoperative delirium and anxiety in patients undergoing coronary artery bypass surgery. The subjects in this study were consisted of patients undergoing CABG in Amiralmomenin Hospital, Kordkoy. This study was a double blind parallel clinical trial. A total of 110 patients, selected based on inclusion and non-inclusion criteria were randomly assigned to the experimental and control groups. Randomization was performed using block randomization. In the experimental group, a CD containing educational short films were given to the patients 4 to 7 days before the operation. Before the operation, Spielberger questionnaire was completed in three stages among the members of both groups to determine the level of anxiety. The first stage was 5-7 days before surgery and before the intervention, the second stage was the day before operation and the third stage was after postoperative extubation. Assessment of delirium as the main outcome was carried out using CAM-ICU scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062828686N1
Registration date: 2017-04-21, 1396/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Kowsar Fahimi
Name of organization / entity
Shahrood University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 5715
Email address
k.fahimi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrood University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of multimedia training on postoperative delirium and pre- and postoperative anxiety in patients undergoing coronary artery bypass graft
Public title
The effect of education on postoperative complications of coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who did not have delirium, unconsciousness, a history of Alzheimer's disease before surgery; no history of coronary artery surgery ؛patients without postoperative complications such as cardiogenic shock, myocardial rupture and ….
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A randomized block design

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
Hafte-Tir Square
City
Shahrood
Postal code
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
IR.SHMU.REC.1395.31

Health conditions studied

1

Description of health condition studied
Coronary Artery Surgery
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Delirium
Timepoint
After Coronary Artery Bypass Surgery
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Anxiety
Timepoint
Before and After coronary artery bypass surgery
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: 4 to 7 days before the operation, a CD containing educational short films by cardiologists, nurses of the ICU open heart surgery and patients who had undergone coronary artery bypass surgery were given to the patients.
Category
Prevention

2

Description
Control group: In the control group, no intervention was operated.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kordkoy Amiralmomenin Hospital
Full name of responsible person
Kowsar Fahimi
Street address
Mirza Kochak Khan Jangali street, Amiralmomenin Square
City
Kordkoy

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shahrood University of Medical Sciences
Full name of responsible person
PHD, Hossein Ebrahimi
Street address
Hafte-Tir Square
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahrood University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Kowsar Fahimi
Position
Intensive Care Nursing Post Graduate Student
Other areas of specialty/work
Street address
Shahid Sayyad Shirazi boulevard
City
Gorgan
Postal code
Phone
+98 17 3254 5715
Fax
Email
k.fahimi@goums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Kowsar Fahimi
Position
Intensive Care Nursing Post Graduate Student
Other areas of specialty/work
Street address
Shahid Sayyad Shirazi boulevard
City
Gorgan
Postal code
Phone
+98 17 3254 5715
Fax
Email
k.fahimi@goums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Kowsar Fahimi
Position
Intensive Care Nursing Post Graduate Student
Other areas of specialty/work
Street address
Hafte-Tir Square
City
shahrood
Postal code
Phone
+98 17 3254 5715
Fax
Email
k.fahimi@goums.ac.ir; k.fahimi68@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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