The main objective of this study is to determine the effect of orientation tour in ICU on patients’ delirium and anxiety incidences after open heart surgery. The research society includes all patients undergoing open heart surgery who will hospitalize in ICU after surgery. The samples of this research will be selected in terms of entry criteria including age, all patients who candidate for non-emergency open heart surgery and exit criteria including to refuse to continue participating in the study. The samples will be put in either the control group or in the test group by using simple random allocation method with 42 per group. To do this, both groups receive the unit routine education and intervention group, in addition to the unit routine education, receives orientation tour intervention which will be held in the form of 30-40-minute tour and they will be orientated with the unit environment, tools and equipment through simulation. In this research, the anxieties of the test and control groups will be measured by Spielbeger anxiety questionnaire at the night before the surgery, after extubating tracheal tube and during the discharge from ICU. Also, delirium will be evaluated by the researcher through ICDSC scale in the morning shift until the patients discharges from ICU and or for 5 days. According to this scale, the score 4 indicates delirium and the score higher than 4 (>4) indicates the incidence of delirium.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052734145N1
Registration date:2017-07-27, 1396/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Ahmad Farajitabar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4329 5187
Email address
farajitabar.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of orientation tour on post-operative delirium and anxiety of patients with open heart surgery
Public title
Effect of orientation tour on the incidence delirium and anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Entry criteria: Age 30-65 years; All patients who candidate for non-emergency open heart surgery; Not with central nervous system disease; No consciousness level disorder; No use of the medicines effecting the psyche
Exit criteria: To refuse to continue participating in the study; The need for re-surgery; Blood transfusion, more than 3 (>3) units
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Rasheed Yasemi Street, Higher than Mirdamad, Vali Asr Street, School of Nud Midwiferyrsing any
City
Tehran
Postal code
-
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.Iums.Rec95-9311449005
Health conditions studied
1
Description of health condition studied
Coronary and valvular heart surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Anxiety
Timepoint
After the intervention, post-extubation and before discharge
Method of measurement
Anxiety Inventory Spielberger
2
Description
Delirium
Timepoint
post orientation tour invention
Method of measurement
Check List of measuring delirium ICDSC
Secondary outcomes
1
Description
Increased length of stay in ICU
Timepoint
Post orientation tour inventio
Method of measurement
ICDSC
2
Description
Increase the duration of mechanical ventilation
Timepoint
Post Orientation tour Invention
Method of measurement
ICDSC
Intervention groups
1
Description
To do this, both groups receive the unit routine education and intervention group, in addition to the unit routine education, receives orientation tour intervention which will be held in the form of 30-40-minute tour and they will be orientated with the unit environment, tools and equipment through simulation
Category
Prevention
2
Description
In control group receive the unit routine education
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Cardiology Fatemehzahra
Full name of responsible person
Ahmad Farajitabar
Street address
Center of Cardiology Fatemehzahra, Boulevard Artesh
City
Sari
2
Recruitment center
Name of recruitment center
Hospital North
Full name of responsible person
Ahmad Farajitabar
Street address
Hospital North,Boulevard Modarres
City
Amol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University Of Medical Science
Full name of responsible person
Syed Ali Javad Mosavi
Street address
Between Sheikh Fadlallah and Chamran Expressway, Hemat Expressway, Iran University of Medical Sciences
City
Tehran
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, Iran University Of Medical Science