Protocol summary
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Study aim
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The effect of nursing interventions on the incidence of delirium after open heart surgery
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Design
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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.
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Settings and conduct
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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 second and third days after surgery will be compared between the experimental and control groups.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria: age over 18 years, being a candidate for Coronary Artery Bypass Graft and being alert at the time of admission (Orientation to time, place, and persons). The non-inclusion criteria: being admitted due to emergency heart surgery, isolation due to infectious disease, deterioration of the patient’s condition after surgery, having a history of previous major surgery, and a lack of consent.
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Intervention groups
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In the intervention group, in addition to routine interventions, patients will receive a video tutorial, and Hospital Elder Life Program (HELP). In the control group, only routine care, including walking once a day in the second and third day of surgery, avoiding dehydration, reminding patients of the use of own glasses and hearing aids will be performed.
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Main outcome variables
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The main outcome variable in this study would be the incidence of delirium.
General information
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Reason for update
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Incorrect recording of inclusion and exclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150724023314N2
Registration date:
2020-02-08, 1398/11/19
Registration timing:
retrospective
Last update:
2020-03-02, 1398/12/12
Update count:
1
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Registration date
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2020-02-08, 1398/11/19
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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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2019-09-01, 1398/06/10
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Expected recruitment end date
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2019-12-30, 1398/10/09
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of nursing interventions on the incidence of delirium after open heart surgery
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Public title
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The effect of a nursing intervention on the incidence of delirium
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age18 years and over
being candidate for Coronary Artery Bypass Graft
being alert at the time of admission (Orientation to time, place, and persons).
Exclusion criteria:
Being admitted due to emergency heart surgery
Isolation due to infectious disease
Deterioration of the patient’s condition after surgery
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be assigned to intervention and control groups using a random number table.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The participants were blinded to whether they had been assigned to the intervention or control group throughout the study.
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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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2019-07-13, 1398/04/22
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Ethics committee reference number
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MUQ.REC.1398.136
Health conditions studied
1
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Description of health condition studied
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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, not induced by alcohol and other psychoactive substances
Primary outcomes
1
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Description
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Incidence of delirium
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Timepoint
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First, second and third day of surgery
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Method of measurement
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CAM-ICU Scale
Intervention groups
1
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Description
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In the intervention group, in addition to routine interventions, patients will receive a video tutorial, and Hospital Elder Life Program (HELP).
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Category
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Prevention
2
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Description
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In the control group, only routine care, including walking once a day in the second and third day of surgery, avoiding dehydration, reminding patients of the use of own glasses and hearing aids will be performed.
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Category
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Prevention
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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Ghoum 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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable