Determining the effect of multifactorial intervention on the prevention of delirium in patients admitted to the intensive care unit of a hospital
Design
A one-phase blind control clinical trial،by sequentially available sampling will be performed on 100 patients admitted to the intensive care unit with consecutive available sampling
Settings and conduct
Participants are unaware of which group they will be in.With daily visits to the intensive care units of trauma, neurosurgery, neurology and internal medicine sampling will be done.First, the control group were completely selected and for the same conditions with the intervention group, each patient was evaluated for delirium for seven days in the morning and evening shifts (6 am and 6 pm).Then intervention group will selected.In both groups, patients will be examined for delirium before enterance to the study and will be excluded if delirium presents.Then, multifactorial intervention will be performed for the intervention group during the first seven days.
Participants/Inclusion and exclusion criteria
inclusion criteria:age>18-No delirium on arrival-new admit patients(less than 24 hour)-absence of cognitive impairement-absence of severe hearing and vision impairment-Organ health in the soles-GCS>9-Awareness or consent to participate in the study (patient or first class companion).Exclusion criteria:discharge, expiration or transfer earlier than 48 hours-Dissatisfaction of the patient or the patient's companion to continue participating in the study
Intervention groups
Interventions include interventions for earplugs and blindfolds, reorientation, setting a calendar and clock and reflexology massage based on the framework of correcting the sensory overload and depriviation and based on valid scientific texts and articles. Control group will receive routine ward care.
Main outcome variables
delirium incidence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049530N1
Registration date:2020-12-05, 1399/09/15
Registration timing:registered_while_recruiting
Last update:2020-12-05, 1399/09/15
Update count:0
Registration date
2020-12-05, 1399/09/15
Registrant information
Name
reyhaneh sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 3314
Email address
reyhaneh.sadeghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multifactorial intervention on prevention of delirium in ICU patients of hospital
Public title
The effect of multifactorial intervention on prevention of delirium in ICU patients of hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age>18
Absence of delirium at the beginning of the study
less than 24 hours from hospitalization
Absence of Cognitive impairment
Absence of severe hearing and vision impairment
Organ health in the soles of the feet
Having the consent or knowledge to participate in the study (patient or first-degree companion)
GCS>9
Exclusion criteria:
Discharge, death or transfer earlier than 48 hours
The unwillingness of the patient or the patient's companion to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, an anesthesiologist evaluates patients for delirium to confirm the researcher's diagnosis, and the statistical analyzer is unaware of whether patients are assigned to a control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
This study is a quasi-experimental study of two groups: an intervention group that receives the mentioned multifactorial interventions and a control group to determine the effect of multifactorial interventions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan university of Medical Sciences
Street address
Kerman, at the beginning of Esteghlal Street, Electronic Signal Store
City
Kerman
Province
Kerman
Postal code
7617798836
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.ZAUMS.REC.1399.345
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium incidence
Timepoint
twice a day, from enterance of patients to the study upto 7 days
Method of measurement
RASS(Richmond Agitation Sedation Scale), CAM-ICU(Confusion Assessment Method for ICU), ICDSC(Intensive Care Delirium Screening Checklist)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Multi-factor intervention for patients in the intervention group will be performed during the first seven days of hospitalization and in the morning (6:30) and evening (6:30). This intervention includes interventions to install earplugs and blindfolds, re-awareness, setting a calendar and clock for the patient and reflexology massage based on the framework of correcting the reduction and increase of sensory stimuli and based on valid scientific texts and scientific articles.
Category
Prevention
2
Description
Control group: This group is evaluated for the onset of delirium with the same tools as the intervention group in the morning and evening (6 o'clock) and receives routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam hospital of Zahedan
Full name of responsible person
Reyhaneh Sadeghian
Street address
Zahedan - Dr. Hesabi Square - Medical Sciences university
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Zahedan - Dr. Hesabi Square - Medical Sciences university
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2117
Fax
+98 54 3337 2117
Email
public@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan medical university
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
Zahedan University of Medical Sciences
Full name of responsible person
Narjes khaton Sadeghi
Position
student, researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kerman, at the beginning of Esteghlal Street, Electronic Signal Store
City
Kerman
Province
Kerman
Postal code
7617798836
Phone
+98 34 3213 3314
Fax
+98 34 3245 9560
Email
reyhaneh.sadeghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Narjes khaton Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zahedan - Dr. Hesabi Square - Medical Sciences University
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
nsadeghi2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Reyhaneh Sadeghian
Position
student, researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kerman, at the beginning of Esteghlal Street, Electronic Signal Store
City
Kerman
Province
Kerman
Postal code
7617798836
Phone
+98 34 3213 3314
Fax
+98 34 3245 9560
Email
reyhaneh.sadeghian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD