To investigate the effect of a role playing-based program about empathy with patients on empathy score of operating room students in Isfahan University Of Nursing and Midwifery in 2017-18
Design
A one-side blinded, 2 groups (control, intervention) clinical trial with 77 samples and per-post test and 1 month follow up in 2017-18
Settings and conduct
This is a single-blinded clinical trial (the analyst does not know which data is belonging to which group) on 77 operating room students at Faculty of Nursing and Midwifery in Isfahan with control and intervention groups. In the intervention group, training about empathy with patient is presented in a role-playing technique. Jefferson's scale of empathy was given to samples in 3 stages before, immediately and 1 month after the intervention. Data is analyzed by SPSS.
Participants/Inclusion and exclusion criteria
Inclusion: Student of operating room/2,4,6,8 semesters student who has the experience of clinical practice and working with patients/Absence of obvious psychological problems /Do not attend in communication with patient or empathy workshops.
Exclusion: Student of operating room (Discontinuous study)/1st semester operating room student/Students with obvious psychological problems/Students participated in workshops about empathy or communication with the patient
Intervention groups
Intervention: Includes a role-playing based empathy training held in 3 sessions (12 hours). In all sessions, one expert psychologist in empathy, helps researcher. The 1st and 2nd sessions focus on empathy and techniques, and in the 3rd session, the samples implement the techniques learned through role-playing with scenario. A questionnaire was given 3 times before, immediately and 1 month after intervention.
Control: participants fill out a questionnaire without receiving intervention
Main outcome variables
Patient's empathy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039726N1
Registration date:2018-07-15, 1397/04/24
Registration timing:retrospective
Last update:2018-07-15, 1397/04/24
Update count:0
Registration date
2018-07-15, 1397/04/24
Registrant information
Name
Negin Larti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3661 3872
Email address
aarabi@nm.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
empty
Scientific title
Study of the Effect of a Role Playing-Based Program about Empathy with Patients on Empathy score in Undergraduate Operating Room Students
Public title
Effect of Patient's Empathy training with Role Playing Method on Empathy score
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Student of undergraduate operating room
Second, fourth, sixth or eighth semester student who has the experience of clinical practice and working with patients
Absence of obvious psychological problems
Do not attend in communication with patient or empathy workshops
Exclusion criteria:
Student of undergraduate operating room (Discontinuous study)
First semester operating room student
Students with obvious psychological problems
Students who previously participated in the workshops about empathy or communication with the patient
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
77
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst is unaware of which data is related to which group (control or intervention)
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services,Faculty of Nursing and Midwifery, Hezarjarib St., Azadi Square.
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.MUI.REC.1396.3.839
Health conditions studied
1
Description of health condition studied
The case in this study is not a disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient's empathy score
Timepoint
Before intervention- immediately after intervention- one month after intervention
Method of measurement
Jefferson scale of empathy (JSE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, a 3-session (12-hour) educational program about empathy with patient, based on role-playing method, in 3 consecutive weeks was conducted for 36 undergraduate operating room students in the Faculty of Nursing and Midwifery, Isfahan. In all the sessions, a psychologist (expert in the field of empathy workshop) helped the researcher. In the first and second sessions, the teaching of empathy topics such as empathy needs, patient empathy techniques and barriers were introduced. In the third session, 36 subjects were divided into 12 groups of 3, and they role-played based on pre-designed scenarios about empathy with patient in the operating room (one of the students played the role of the patient and two others played the role of the nurse in the room) and practiced empathy techniques.
Category
Behavior
2
Description
Control group: There was no intervention in this group and 41 patients in this group, just responded to the patient's empathy questionnaire in 3 phases. However, in order to comply with the ethics principle in the research, it was suggested to the students that if they want, the training would be carried out for them, after the end of the research.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Akram Aarabi
Street address
School of Nursing and Midwifery, Isfahan university of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7510
Email
aarabi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Akram Aarabi
Street address
school of Nursing and Midwifery, Isfahan University Of Medical Sciences, Hezar Jarib Street, Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7510
Email
aarabi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Negin Larti
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Department of Operating Room, School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3661 3872
Email
surgicaltechnologist89@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Akram Aarabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Operating Room, School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7510
Email
aarabi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negin Larti
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 239, 8th Alley., Shahid Kiani Street., Feiz Street
City
Isfahan
Province
Isfehan
Postal code
81658-17641
Phone
+98 31 3661 3872
Email
surgicaltechnologist89@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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 total potential data can be shared after unidentifiable people.
When the data will become available and for how long
The start of the access period is after publishing the data.
To whom data/document is available
Data will be available to researchers and students working in academic, scientific and clinical settings.
Under which criteria data/document could be used
All people working in science centers have access to data.
From where data/document is obtainable
Refer to the scientific officer for this study.
Email: aarabi@nm.mui.ac.ir
What processes are involved for a request to access data/document
It is possible to contact the scientific research officer by Email.