Effect of nursing interventions and scheduled appointments versus control group on prevention of delirium in patients hospitalized in intensive care unit: a randomized clinical trial
To assess the effect of nursing interventions and scheduled appointments versus control group on prevention of delirium in patients hospitalized in intensive care unit
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the cluster randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Beheshti Hospital in Hamadan city on 96 eligible patients hospitalized in intensive care unit. The patients will be randomly assigned to the intervention and control groups through the cluster randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Indication for hospitalization in the intensive care unit
Exclusion criteria:
Cognitive disease
Alcohol and drug addiction
Visual or auditory disorders
Loss of consciousness
Taking psychoactive drugs
History of stroke or liver cirrhosis or kidney failure
Intervention groups
Intervention group 1:
The routine care of the ward in addition to nursing interventions including installing clocks and calendars in front of patients to inform them of the place and time, using appropriate light during the day and night, listening to radio and music and encouraging patients to increase mobility, informing patients about time, place and recent events.
Intervention group 2:
Routine care of the ward in addition to the scheduled appointments including washing the mouth and combing the patients' hair and encouraging them to drink fluids, as well as touching the patients and talking to them about their daily events and topics of interest.
Control group:
Only routine care of the ward
Main outcome variables
Primary outcome:
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N460
Registration date:2023-02-05, 1401/11/16
Registration timing:prospective
Last update:2023-02-05, 1401/11/16
Update count:0
Registration date
2023-02-05, 1401/11/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nursing interventions and scheduled appointments versus control group on prevention of delirium in patients hospitalized in intensive care unit: a randomized clinical trial
Public title
Effect of nursing interventions and scheduled appointments versus control group on prevention of delirium in patients hospitalized in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Indication for hospitalization in the intensive care unit
Exclusion criteria:
Cognitive disease
Alcohol and drug addiction
Visual or auditory disorders
Loss of consciousness
Taking psychoactive drugs
History of stroke or liver cirrhosis or kidney failure
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to intervention and control groups using cluster randomization method. For this purpose, three wards are considered, two wards are assigned to the intervention groups and one ward is assigned to the control group. Then, with enrolment of each patient, one of the wards is randomly selected and accordingly the patient is assigned to the relevant ward and group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.UMSHA.REC.1401.938
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
Timepoint
On the first, second and third days after the intervention
Method of measurement
Using the CAM-ICU tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The routine care of the ward in addition to nursing interventions including installing clocks and calendars in front of patients to inform them of the place and time, using appropriate light during the day and night, listening to radio and music and encouraging patients to increase mobility, informing patients about time, place and recent events.
Category
Treatment - Other
2
Description
Intervention group 2: Routine care of the ward in addition to the scheduled appointments including washing the mouth and combing the patients' hair and encouraging them to drink fluids, as well as touching the patients and talking to them about their daily events and topics of interest.
Category
Treatment - Other
3
Description
Control group: Only routine care of the ward
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Parvaneh Ghaderi
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
parvaneh.ghaderi7313@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Parvaneh Ghaderi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
parvaneh.ghaderi7313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Morteza Shamsiadeh
Position
Master of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mortezashamsizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available