Evaluation of the effectiveness of intelligent simulator of effective communication with the patient on self-efficacy, satisfaction, and caring behavior of nursing students
Identifying the effectiveness of an intelligent simulator of effective communication with the patient in the psychiatric ward on satisfaction, self-efficacy, and caring behavior of nursing students
Design
This is a double-blind parallel clinical trial. This study will be performed on 70 students. Eligible students will be divided into two groups of intervention and control. The sample size will be estimated at 62 people for both groups based on a previous study. Due to the possibility of losing participants in the study process, the sample size will be considered 70 people.
Settings and conduct
Students of the control group, after completing the study questionnaires, according to the usual routine, receive the necessary explanations about the department from their professor and enter the department. Students of the intervention group will interact with virtual patients through a simulator before entering the ward environment. It should be noted that before using the simulator, study questionnaires will be completed by students in the intervention group. After using the simulator, the students of the intervention group enter the ward like the control group and perform their routine tasks. At the end of the first day internship, both groups will complete the study questionnaires again.
Participants/Inclusion and exclusion criteria
Inclusion criteria include being a student of 6th-semester undergraduate at Shiraz School of Nursing, willingness to participate in the study. The exclusion criteria are the impossibility or withdrawal of participating in the study and the experience of mental health patient communication.
Intervention groups
Students in the intervention group will use a computer simulator with different scenarios before entering the mental ward, and students in the control group will receive the usual training.
Main outcome variables
Efficacy; Nursing students' caring behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201001048893N3
Registration date:2022-03-09, 1400/12/18
Registration timing:prospective
Last update:2022-03-09, 1400/12/18
Update count:0
Registration date
2022-03-09, 1400/12/18
Registrant information
Name
Maryam Shaygan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 7345
Email address
m2620.shaygan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of intelligent simulator of effective communication with the patient on self-efficacy, satisfaction, and caring behavior of nursing students
Public title
Assessment of the effectiveness of intelligent simulator of effective communication with the patient on self-efficacy, satisfaction, and caring behavior of nursing students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be a 6th-semester undergraduate student of Hazrat Fatemeh School of Nursing and Midwifery in Shiraz.
Willingness to participate in the study
Exclusion criteria:
Impossibility or withdrawal of the student from continuing to participate in the research at any stage of the study
Having previous experience communicating with a patient with a mental disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this research project, nursing students will be randomly divided into two groups of intervention and control on the first day of internship in the psychiatric ward, immediately before entering the ward by a person outside the study. In this way, the numbers of all the groups are thrown into a container in the form of folded papers (the number of which cannot be seen) and then an out-of-study person is asked to take half of the folded papers out of the container by chance. The extracted papers will form the intervention group. Since students enter different wards of Ibn Sina Psychiatric Hospital in Shiraz in different groups, in order to prevent data contamination, instead of randomizing students in the intervention and control groups, the whole group will be a randomization unit, so that half The groups will be randomly assigned to the intervention group and the other half to the experimental group (cluster randomization).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, in order to blind and prevent possible bias, dividing the groups into two groups, distributing and collecting questionnaires, interpreting the questionnaire, entering and interpreting the data and analyzing the information in statistical software will be done with the help of researchers and statistical experts outside the study. In addition, the data analyst will be unaware of the grouping of students.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the center in the National Center for Strategic Research in Medical Education
This intervention is an interactive communication program and scenarios will be designed in which the user plays the role of a nurse and communicates with the virtual patients. In this program, three scenarios will be designed for each of the depressive, bipolar and schizophrenic diseases. The simulator program includes interacting with virtual patients and receiving appropriate feedback. Scenarios in which the user plays the role of a nurse and communicates with virtual patients will be created in such a way that the users of the program will choose the answer that they consider appropriate for that situation. After logging in, the user interacts with virtual patients in various clinical situations. The user selects an appropriate answer from the multiple-choice questions during the interaction and receives feedback on its correctness or incorrectness. The correct answer will be reminded if the user's response is incorrect. A total of 5 to 10 nurse-patient communication skills will be designed for each scenario. In this study, the students of the intervention group will interact with virtual patients through a simulator in the assembly hall of the hospital before entering the environment of the psychiatric ward. The duration of using the simulator will be decided after its design and based on the opinion of psychiatric nursing professors.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Hospital
Full name of responsible person
Maryam Shaygan
Street address
Avicenna Medical Educational Center, next to 13 Aban Park, Hafez St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3228 9601
Fax
+98 71 3228 0236
Email
sinahosp@sums.ac.ir
Web page address
https://ebnesina.sums.ac.ir/page-ebnesinahp/fa/43
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
the center in the National Center for Strategic Research in Medical Education
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the center in the National Center for Strategic Research in Medical Education
Proportion provided by this source
53
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
2
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpoor
Street address
Zand St., Central Building of Shiraz University of Medical Sciences, 7th floor, Vice Chancellor for Research and Technology
City
Shiraz
Province
Fars
Postal code
14336- 71348
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/
Grant name
SG-00-14
Grant code / Reference number
SG-00-14
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
48
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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4287
Email
m2620.shaygan@gmail.com
Web page address
https://sums.ac.ir/page-cbpcrc/fa/207
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3367 4254
Fax
+98 71 3647 4287
Email
m2620.shaygan@gmail.com
Web page address
https://sums.ac.ir/page-cbpcrc/fa/207
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3367 4254
Fax
+98 71 3647 4287
Email
m2620.shaygan@gmail.com
Web page address
https://sums.ac.ir/page-cbpcrc/fa/207
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Anonymous study data will be shared in correspondence with the project manager
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Systematic reviews and meta-analyses
From where data/document is obtainable
Contact via email:
m2620.shaygan@gmail.com
What processes are involved for a request to access data/document
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.