Protocol summary

Study aim
Comparison of the Effect of Patient Rights Charter Training in Written Simulation and Computerized Virtual Patient Simulation on Ethical Sensitivity of Intensive Care Nurses
Design
A clinical trial with control group, single blinded, randomized
Settings and conduct
The present study is a clinical trial in 1397. The study population was nurses working in intensive care units of hospitals affiliated to Tehran University of Medical Sciences. After obtaining permission from the Joint Organizational Ethics Committee of Faculty of Nursing and Midwifery and Rehabilitation of Tehran University of Medical Sciences, research samples (Nurses of Intensive Care Units) with inclusion criteria will be divided into three groups using blocking method.
Participants/Inclusion and exclusion criteria
Inclusion criteria included nurses in intensive care units who had worked in that department for at least one year, a willingness to participate in the study, a bachelor's degree in nursing, and no previous two-month ethics seminar or workshop. Exclusion criteria included nurses' unwillingness to continue research in any part of the study, conducting a ethics workshop or seminar during the two months after intervention and transferring to another department while collecting data.
Intervention groups
Simulation group using virtual patient simulation, simulation group using written simulation, control group
Main outcome variables
Nurses' moral sensitivity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111203008286N6
Registration date: 2019-10-10, 1398/07/18
Registration timing: prospective

Last update: 2019-10-10, 1398/07/18
Update count: 0
Registration date
2019-10-10, 1398/07/18
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of training the patient's bill of right through written simulation and virtual Computerized simulated patient simulation on moral sensitivity of critical care nurses
Public title
Training the patient's bill of right
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Intensive Care Nurses Has worked in that department for at least one year Willingness to participate in the study Bachelor of Nursing Degree No record of attending seminars or workshops about ethics in the past two months
Exclusion criteria:
Nurses' unwillingness to continue research in any part of the study Conducting a workshop or seminar about ethics during the two months following the intervention Move to another section while collecting data
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, a number of cards are selected by the researcher as the first group (first intervention) and the same number for the second group (intervention 2) and the third (control). The expired card will be registered and assigned, and the card will be returned to all other cards after it has expired. The cards are then merged with the card and another card is removed. This process continues until a random sequence of sample size is obtained.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tohid Square, Dr. Mirkhani St. (East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.TUMS.FNM.REC.1398.078

Health conditions studied

1

Description of health condition studied
Moral sensitivity, Ethical sensitivity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Ethical sensitivity score according to Lutzen moral sensitivity questionnaire
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Lutzen moral sensitivity questionnaire

Secondary outcomes

1

Description
Moral Judgments score
Timepoint
Before and two months after intervention
Method of measurement
Moral Judgments questionnaire

Intervention groups

1

Description
Intervention group: In the virtual simulation training group, the scenarios will be described as a learning personality for the learners. Then, at the end of training and two months after training in each of the intervention groups, the Lutzen moral sensitivity questionnaire was completed by the samples
Category
Other

2

Description
Control group: After expressing the aims of the study and completing the informed consent form for the control group, the ethical sensitivity questionnaire was completed at the beginning and two months after the selection of the samples and after the end of the study, the text taught to the intervention group will be provided to the control group.
Category
N/A

3

Description
Intervention group 2: In the simulated group, first the researcher is instructed by the researcher about the Patient Rights Charter, then the same two scenarios are presented to the research units in the computer simulated virtual patient group with the same options, this time in writing to Research units are provided. If the wrong option is selected, the researcher will be given the necessary suggestions and suggestions, and if the correct option is selected, the research units will be encouraged by the researcher and the next scenario will be presented in writing.Then, at the end of the training and two months after training in each of the intervention groups, the Lutzen Ethical Sensitivity Questionnaire was completed by the samples.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Faezeh Parchami
Street address
Imam Khomeini Hospital, End of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6105 4416
Email
parchami.fza@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
DR.Sahraian
Street address
Tehran University of Medical Sciences, Qodes Street, KEshavarz Blvd., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Fax
Email
vcr@tums.ac.ir
Web page address
http://www.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
00982166927171, 00982161054000
Email
bahramnezhad.f@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
00982166927171, 00982161054000
Email
bahramnezhad.f@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Parchami
Position
Ms student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
66927171-61054000
Email
parchami.fza@gmail.com

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
Loading...