The effect of multifaceted nursing interventions on clinical outcomes and quality of life of patients with delirium admitted to the intensive care unit
This study aims to determine the impact of multifaceted nursing interventions on clinical outcomes and quality of life of patients with delirium hospitalized in the intensive care unit.
Design
A controlled clinical trial with parallel groups will be conducted on 52 patients.
Settings and conduct
This study will be conducted in Golestan and Imam Khomeini teaching hospitals in Ahvaz on delirium patients admitted to the intensive care unit. In the intervention group, the intervention will be done in three stages. The first stage of training, the second stage will be creating changes in the ward environment and the third stage will be the installation of educational posters on how to deal with patients at risk of delirium.
Participants/Inclusion and exclusion criteria
inclusion criteria:
• Hospitalization in the ICU
Having a state of restlessness, sleepiness and hallucinations after being hospitalized in the ICU and suffering from delirium according to the RASS criteria and confirmed by a doctor
Non-inclusion criteria:
• Having a history of previous psycho-cognitive illness through medical history
Intervention groups
Intervention group: In this group, training , interventions in the environment of the department and installed educational posters will be performed.
Control group: In this group, routine interventions will be performed.
Main outcome variables
Glasgow coma scale (GCS), agitation and sedation, quality of life, duration of hospitalization, severity of delirium and mortality rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221121056568N1
Registration date:2022-11-26, 1401/09/05
Registration timing:prospective
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
noushin Rostami monjezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3839
Email address
rostami.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multifaceted nursing interventions on clinical outcomes and quality of life of patients with delirium admitted to the intensive care unit
Public title
The effect of multifaceted nursing interventions on patients admitted to the intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in the ICU
Having restlessness, sleepiness and hallucinations after being hospitalized in the ICU and suffering from delirium according to the RASS criteria and confirmed by a doctor
Exclusion criteria:
Having a history of previous psycho-cognitive illness through medical history
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Not 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 Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.AJUMS.REC.1401.244
Health conditions studied
1
Description of health condition studied
Patients with delirium admitted to the intensive care unit
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
level of consciousness
Timepoint
Before and after the intervention
Method of measurement
Glasgow scale
2
Description
Agitation and sedation of patients
Timepoint
Before and after the intervention
Method of measurement
Richmond Criterion
3
Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the intervention is done in three stages. In the first stage, training of employees will be done in the form of holding educational workshops and pamphlets. The second stage is creating environmental interventions in the department, which includes installing clocks and calendars in front of the patient, allowing the patient to meet with family members, using appropriate light during the day and night, providing glasses and hearing aids to the patient, using optical alarms to Instead of sound alarms, encouraging the staff to interact more with the patient, encouraging the patient to drink fluids in case of dehydration and leaving the bed. The third stage will include the installation of an educational poster on how to deal with patients at risk of delirium and a step-by-step guide for dealing with delirium patients in the department.
Category
Other
2
Description
Control group: Routine interventions will be performed in this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Davoud Shalil-ahmadi
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715795
Phone
+98 61 3311 3562
Email
golestanjpspital@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ahmadreza Mohtadi
Street address
Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715797
Phone
+98 61 2222 2818
Email
imam-hospitalajums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zaker kish
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2411
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Marziyeh Asadi-zaker
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
marziyehasadizaker@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marziyeh Asadi-zaker
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
marziyehasadizaker@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Rostami monjezi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6135715798
Phone
+98 61 3333 3839
Fax
Email
rostami.n@ajums.ac.ir
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
There is no further information.
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
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