Protocol summary

Study aim
to determine the effect of professional ethicseducation through mobile application on moral sensitivity and moral distress of operating room personnel
Design
moral sensitivity and moral distress questionnaires will be provided to the participants of both groups. Then, the pre prepared educational materials are provided to the intervention group in the form of mobile application. For the people of the control group, the electronic training booklet will be sent in full through the mobile messenger. The intervention period will be 4 weeks. After the intervention, moral sensitivity and moral distress questionnaires will be collected again immediately and 2 months after the end of the intervention between the two intervention and control groups, distribution and data will be collected.
Settings and conduct
All operating room personnel in two teaching hospitals In order to blind the study, distribution and collection of questionnaires and data analysis will be done by people who do not know about the distribution of samples in groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria Having at least 6 months of work experience in the operating room, at least an associate's degree in the fields of operating room, intelligence and nursing able to use mobile software and their phone is equipped with Android. Exclusion criteria Not using educational software in the intervention group Participation in the training workshop on professional ethics in the operating room during the last 6 months
Intervention groups
two teaching hospitals that have similar operating rooms will be selected. Then, 64 qualified nurses from each operating room will be selected and entered into the study by available sampling method
Main outcome variables
Moral sensitivity measured by Lutzen et al.'s modified 25 item questionnaire and moral distress measured by Corley's revised 21 item questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240630062281N1
Registration date: 2024-07-04, 1403/04/14
Registration timing: prospective

Last update: 2024-07-04, 1403/04/14
Update count: 0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
Abbas Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3533 0210
Email address
abasrezaee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of professional ethics education through mobile application on moral sensitivity and moral distress of operating room personnel
Public title
The effect of professional ethics education through mobile application on moral sensitivity and moral distress of operating room personnel
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 6 months of experience in the operating room Having at least an associate's degree in the fields of operating room, intelligence and nursing Be able to use mobile software and their smartphone should be equipped with Android operating system Absence of mental disorder and non-use of antidepressants or drugs related to mental disorders by self-reporting method by personnel
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study, distribution and collection of questionnaires and data analysis will be done by people who do not know about the distribution of samples in groups. Also, in order to avoid the connection between the two control and intervention groups, this study will be conducted in two different hospitals, and the people of one hospital will be considered as the control group and the other hospital will be considered as the intervention group.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Nawab Safavi Blvd., Danesh Payeh Blvd., Shahid Abbas Eslami Alley
City
Yazd
Province
Yazd
Postal code
8918844678
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.SUMS.REC.1403.109

Health conditions studied

1

Description of health condition studied
Moral sensitivity and moral distress of operating room personnel
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Moral sensitivity is the score given by respondents to the 25 item questions of Lutzen et al.'s Modified Moral Sensitivity Questionnaire (MMSQ). The score range of this questionnaire will be between 0 and 100, which is scored based on a 5-point Likert scale. The highest score is 100 and the lowest score is zero. Therefore, if the total score of each sample is between 0 and 50, it is considered as having low moral sensitivity, 50 to 75 as medium sensitivity, and 75 to 100 as high moral sensitivity. Moral distress will be used from the revised 21item questionnaire of Corley 2001, which is scored on a 5-point Likert scale. The minimum score is 0 and the maximum score is 336, a higher score indicates more moral distress of the person
Timepoint
The pre-test phase will be held at the beginning of the study for all the participants in the study, and the moral sensitivity and moral distress questionnaires will be provided to the participants of both groups as a pre-test. The intervention period will be 4 weeks. After the completion of the intervention, moral sensitivity and moral distress questionnaires will be collected again immediately and 2 months after the end of the intervention between the two intervention and control groups, distribution and data will be collected.
Method of measurement
Moral sensitivity is the score given by the respondents to the 25 item questions of Lutzen et al.'s adjusted moral sensitivity questionnaire. Moral distress will be used from the revised 21 item questionnaire of Corley 2001, which is scored on a 5-point Likert scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pre-prepared educational materials that include professional ethics training in the form of mobile phone software, which will be approved by the professors of the nursing school and the electronic center of Shiraz University of Medical Sciences; It will be provided to the intervention group and it will be installed on their mobile phone or tablet (equipped with Android operating system) and how to work with the software will be explained to them and the software usage guide will be provided to them. will be placed To ensure the use of the software by the people in the intervention group, a text message will be sent to the researcher every time they enter the software, and also every week until the end of the intervention, with follow-up through a group created in the Ita messenger and WhatsApp for the people in the intervention group. The software will be reviewed. The intervention period will be 4 weeks. During this period, the people of the intervention group become members in a group managed by the researcher, in one of the social networks. In the group, there will be a group discussion with the researcher about the contents of the software and the provided training, and their questions will be answered.
Category
Other

2

Description
Control group: Control group: It will be done according to the usual method of holding educational courses in the hospital, where educational resources are provided to the personnel through mobile phone messengers, and pamphlets will be sent to them through mobile phone messengers (ITA and WhatsApp). Electronic training will be sent in full. The control group will not receive any intervention via mobile phone and the relevant training will be provided to them in the form of an electronic training booklet according to the usual method of the hospital.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd teaching hospitals
Full name of responsible person
Marzieh Momen Nasab
Street address
Nawab Safavi Blvd., Danesh Payeh Blvd., Shahid Abbas Eslami Alley
City
Yazd
Province
Yazd
Postal code
8918844678
Phone
+98 35 3533 0210
Email
abasrezaee@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Nawab Safavi Blvd., Danesh Payeh Blvd., Shahid Abbas Eslami Alley
City
Yazd
Province
Yazd
Postal code
8918844678
Phone
+98 35 3533 0210
Email
abasrezaee@sums.ac.ir
Grant name
Grant code / Reference number
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaee
Position
Msc of operating room
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Nawab Safavi Blvd., Danesh Payeh Blvd., Shahid Abbas Eslami Alley
City
Yazd
Province
Yazd
Postal code
8918844678
Phone
+98 35 3533 0210
Email
abasrezaee@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaee
Position
Msc of operating room
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Nawab Safavi Blvd., Danesh Payeh Blvd., Shahid Abbas Eslami Alley
City
Yazd
Province
Yazd
Postal code
8918844678
Phone
+98 35 3533 0210
Email
abasrezaee@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaee
Position
Msc of operating room
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Nawab Safavi Blvd., Danesh Payeh Blvd., Shahid Abbas Eslami Alley
City
Yazd
Province
Yazd
Postal code
8918844678
Phone
+98 35 3533 0210
Email
abasrezaee@sums.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
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
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