Protocol summary

Study aim
Comparison of the effect of lecture and jigsaw training on nurses' attitudes towards delirium and the ability to screen for delirium in intensive care units.
Design
A parallelو un blindedو two-group, randomized clinical trial
Settings and conduct
Two groups are determined through simple randomization with the help of Excel software and random number function. At first, the demographic information questionnaire and delirium attitude assessment are completed by the samples. To check the ability of delirium screening, 3 clinical scenarios will be provided to each nurse and the nurse will score each patient based on the tool. Then, the intervention including the Jigsaw method training program will be presented for 4 sessions in groups of 3 to 5 nurses and in the lecture group for 2 sessions, and the questionnaires will be completed again and the scores will be compared. The study is carried out in the ICUs of hospitals affiliated to Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Have at least a bachelor's degree in nursing - Have at least one year of clinical work experience in the intensive care unit -They have not completed a training course related to delirium in the past year Exclusion criteria: - Leave the intensive care unit before completing the study for any reason - Have not completed the questionnaires completely - Absence of more than one session during the presentation of the educational program
Intervention groups
The interventions include the implementation of delirium training by the jigsaw method for nurses in one group and training by the lecture method in another group.
Main outcome variables
- The attitude of nurses towards delirium - Screening ability of nurses in the diagnosis of delirium in ICU

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230301057573N1
Registration date: 2023-03-23, 1402/01/03
Registration timing: prospective

Last update: 2023-03-23, 1402/01/03
Update count: 0
Registration date
2023-03-23, 1402/01/03
Registrant information
Name
Syede Mohadese Nabizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4223 5821
Email address
mohadesenabizade@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Lecture and Jigsaw Training on Nurses' Attitude towards Delirium and the Ability to Screen for Delirium in the Intensive Care Unit
Public title
Investigating the effect of lecture and jigsaw training on nurses' attitudes towards delirium and the ability to screen for delirium.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least a bachelor's degree in nursing Have at least one year of clinical work experience in the intensive care unit They have not completed a training course related to delirium in the past year Due to the importance of having at least one year of work experience in the ICU, the age of entering the study is 23 years and older.
Exclusion criteria:
Leave the intensive care unit before completing the study for any reason Have not completed the questionnaires completely Absence of more than one session during the presentation of the educational program
Age
From 23 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using Excel software and random number function. One hospital is selected for the first intervention group (jigsaw training) and the other hospital for the second group (lecture training). Random allocation will be done by the method of random sequence generation by random number table in Excel software. In the Excel software page, the left column, the total number of participants shows that there are 80 people in the present study. The next column indicates the group to which the participants belong, using which the top half will eventually belong to group A and the bottom half to group B. In the following, after identifying the people in two groups, to cover the allocation to the two groups, two dark and closed and completely similar envelopes are used, in one envelope the name of hospital A and in the second envelope, the name of hospital B is written and randomly one The envelope is selected and the selected hospital is selected for the first intervention (jigsaw) and accordingly the second hospital is selected for the second intervention (lecture).
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
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
hahid Chamran Highway, Yemen Street - Shahid Arabi Street, next to Ayatollah Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.231

Health conditions studied

1

Description of health condition studied
Delirium in the intensive care unit
ICD-10 code
F13.221
ICD-10 code description
Sedative, hypnotic or anxiolytic dependence with intoxication delirium

Primary outcomes

1

Description
Nurses' attitude score towards delirium
Timepoint
At the beginning of the study (before the start of the intervention) and four weeks after the intervention.
Method of measurement
The instrument of nurses' attitude towards delirium includes 38 items with a 1-5 Likert scale (from completely disagree to completely agree) and has four areas of knowledge, ability and self-confidence, ability to identify and understand the consequences, desire to know more and burden of care. In this questionnaire, the minimum score is 38 and the maximum score is 190.

2

Description
Nursing Delirium Screening Scale
Timepoint
At the beginning of the study (before the start of the intervention) and four weeks after the intervention.
Method of measurement
The delirium screening nursing tool have 5 dimensions, including impaired consciousness, inappropriate behavior, inappropriate communication, perceptual sensory error/hallucinations, psychomotor delay, each dimension is scored from 0 to 2 based on the conditions.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group (lecture): In this group, education related to delirium includes the definition and types of delirium in the ICUs, identification methods of delirium, important interventions in the prevention and care of patients, and appropriate treatment and care methods, etc. for two sessions of 30 minutes. It is presented to nurses through a lecture and PowerPoint and movie screening by the researcher.
Category
Other

2

Description
The second intervention group: in the jigsaw learning method, nurses are divided into groups of 3 to 5 people. Delirium topics are presented in 4 sessions of 30 minutes. Every week, according to the PowerPoint chapter and educational video designed, nurses will be informed about the topic and all members of the group will study the desired topic. After the meeting, one group leader will be selected from each group and the educational content will be presented to them through the researcher. Then the specified members of each group will form a group of experts together and will review the desired educational topic with their participation and have a comprehensive review of the concepts of the topic and master the components of the topic in the presence of the researcher. The group will return and present the concepts to their group members, and then the researcher will summarize the topics and this process will continue for four weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Seyede Mohadese Nabizade
Street address
Imam Hossein Square, the beginning of Shahid Madani Street, Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
mohadesenabizade@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Seyede Mohadese Nabizade
Street address
Tajrish Square - ShohadayeTajrish Hospital
City
Tehran
Province
Tehran
Postal code
19899 34148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghie
Street address
Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
mohadesenabizade@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Sanaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Hashemi Rafsanjani Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
nedasanaie@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Sanaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Hashemi Rafsanjani Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
nedasanaie@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Sanaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Hashemi Rafsanjani Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
nedasanaie@sbmu.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
Yes - There is 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
Title and more details about the data/document
The result of data analysis of all participants in the study
When the data will become available and for how long
After publish
To whom data/document is available
researchers
Under which criteria data/document could be used
no person
From where data/document is obtainable
Send email to the correspond author of the article
What processes are involved for a request to access data/document
About a week
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