History
# Registration date Revision Id
2 2020-02-14, 1398/11/25 124100
1 2020-02-08, 1398/11/19 121080
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
The effect of nursing interventions on the incidence of delirium after open heart surgery
Design
In this study, 60 patients were conveniently sampled and randomly allocated to the experimental and control groups. The random number table will be used for random allocation. Blinding will not be performed in this study. The CAM-ICU scale will be used for diagnosis of delirium.
Settings and conduct
This study will be conducted in the intensive care unit of Shahid Beheshti Hospital in Qom. Interventions will begin immediately after open heart surgery.The intervention will last for three days. Blinding will not be performed in this study. The incidence of delirium in the first, second and third days after surgery will be compared between the experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient's satisfaction to participate in the survey; age over18 years; lack of alcoholism; being healthy vision and hearing or eliminating defects by using of eyeglasses or hearing aids. Exclusion criteria: transferring the patient to the other units; cardiopulmonary resuscitation and died of patient.
Intervention groups
In the experimental group, in addition to routine care, nursing interventions included teaching nursing staffs about the diagnose and care for patients with delirium, put a clock and calendar in exposing the patients, reducing ambient light at night, using glasses for patients with eye problems, and using hearing aids for patients with hearing problems will be don. In the control group, only routine care, including allowing the patient to meet with their family and reducing the noise of environments during the night will be performed.
Main outcome variables
The main outcome variable in this study would be the incidence of delirium.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150724023314N2
Registration date: 2020-02-08, 1398/11/19
Registration timing: registered_while_recruiting

Last update: 2020-02-08, 1398/11/19
Update count: 1
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Qom university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3242 4753
Email address
mabasiniya@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing interventions on the incidence of delirium after open heart surgery
Public title
The effect of a nursing intervention on the incidence of delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age18 years and over Lack of understanding and underlying disease such as dementia No alcohol addiction Being healthy vision and hearing or eliminating defects by using of eyeglasses or hearing aids No use of psychotropic drugs
Exclusion criteria:
Patient's unwillingness to continue participating in the study Transfer the patient to another ward or medical center Starting sedation drugs Cardiopulmonary resuscitation
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using a random number table.
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 Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street, Qom.
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2019-07-13, 1398/04/22
Ethics committee reference number
MUQ.REC.1398.136

Health conditions studied

1

Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium, not induced by alcohol and other psychoactive substances

Primary outcomes

1

Description
Incidence of delirium
Timepoint
First, second and third day of surgery
Method of measurement
CAM-ICU Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the experimental group, in addition to routine care, nursing interventions included teaching nursing staffs about the diagnose and care for patients with delirium, put a clock and calendar in exposing the patients, reducing ambient light at night, using glasses for patients with eye problems, and using hearing aids for patients with hearing problems will be don.
Category
Prevention

2

Description
Control group: In the control group, only routine care, including allowing the patient to meet with their family and reducing the noise of environments during the night will be performed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Qom
Full name of responsible person
Mohammad Abbasinia
Street address
Shahid Beheshti Hospital, Shahid Beheshti Boulevard, Qom
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2112
Email
armak1364@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Hosori
Street address
No. 83, University of Jihad Alley, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
9345637169
Phone
+98 25 3285 2720
Email
hozori@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Abbasinia
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 83, University of Jihad Alley, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
9345637169
Phone
+98 25 3285 2720
Email
armak1364@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Abbasinia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 83, University of Jihad Alley, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
9345637169
Phone
+98 25 3285 2720
Email
armak1364@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Abbasinia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 83, University of Jihad Alley, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
9345637169
Phone
+98 25 3285 2720
Email
armak1364@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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