Protocol summary

Summary
The aim of this study is to determine the effect of ethical principles education on nurses' attitude and ethical sensitivity toward elder patients admitted in selected hospitals. In this clinical randomized trial research, two hospitals are randomly selected and randomly divided into intervention and control groups. 80 nurses participate in this study. Ethical sensitivity questionnaire and attitude towards elderly people are completed by nurses.The inclusion criteria include: having a bachelor degree in nursing؛ employed in selected hospitals of Shiraz University of Medical Sciences؛ Nurses tend to participate in the study؛ Nurses who take care of the elderly patients. Exclusion criteria: not willing to continue to work؛ do not complete the questionnaire correctly. The study sample (n=80) are selected purposely, voluntarily and allocated into two groups including intervention and control groups by block randomization method. The baseline measurements include nurses' attitude and ethical sensitivity toward elder patients. For the intervention group, 4 sessions of 2 hours per week are organized (face-to-face and group presentation, ethics training group discussions) at the beginning and 8 weeks after the end of the intervention. Moral sensitivity questionnaire and attitude towards elderly people questionnaire are completed each time. Data are collected using moral sensitivity and attitude towards elderly people questionnaires. Expected outcome is the difference in moral sensitivity and attitude toward elder people in intervention group to compare with control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015072223279N3
Registration date: 2017-09-24, 1396/07/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
Shahrzad Yektatalab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
yektash@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of ethical principles education on nurses' attitude and ethical sensitivity toward elder patients
Public title
The impact of ethical principles education on nurses' attitude and ethical sensitivity toward elder patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Having a bachelor's degree in nursing؛ Being employed in selected hospitals of Shiraz University of Medical Sciences؛ Nurses tend to participate in the study؛ Nurses have taken care of the elderly patients in their own ward. exclusion criteria: Unwilling to continue studying؛ Inability to continue collaboration due to physical or mental accident during the study period؛ There is a defect in the correct completion of the questionnaires.
Age
No age limit
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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The allocation of Namazi and Shahid Faghihi hospitals to case and control groups was done by simple randomization method and drawing.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Avenue - Central Building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.SUMS.REC.1396.37

Health conditions studied

1

Description of health condition studied
The impact of ethical principles education on nurses' attitude and ethical sensitivity toward elder patients
ICD-10 code
_
ICD-10 code description
_

Primary outcomes

1

Description
ethical sensitivity
Timepoint
Before the intervention, immediately after the intervention and two months after the intervention
Method of measurement
Lutzen Moral Sensitivity Questionnaire

Secondary outcomes

1

Description
Attitude toward elder adult
Timepoint
Befor, after and 8 weeks after the intervention
Method of measurement
Kogan Attitude Towards Elderly People Scale

Intervention groups

1

Description
Intervention group: Nurses will participate in 4 sessions of the 2-hour ethics training course, which will be held on a weekly basis and complete Moral Sensitivity Questionnaire and Kogan's Attitudes toward Older People Scale at the beginning of the plan, 4 weeks and 12 weeks after the start of the project.
Category
N/A

2

Description
Control group: Nurses don't attend any classroom and only complete Moral Sensitivity Questionnaire and Kogan's Attitudes toward Older People Scale at the beginning of the plan, 4 weeks and 12 weeks after the start of the project.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Zahra Azadi
Street address
Shiraz, Zand Avenue, Namazi Square, Namazi Hospital
City
Shiraz

2

Recruitment center
Name of recruitment center
Shahid Faghihah Hospital
Full name of responsible person
Nilofar Niakan
Street address
Shiraz, Zand Avenue, Faculty of Medicine, Shahid Faghihah Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Zand Blvd, Central Building of Shiraz University of Medical Sciences, 7th floor
City
Shiraz
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Hazrat Fatemeh
Full name of responsible person
Dr. Shahrzad Yektatalab
Position
Assistant Professor
Other areas of specialty/work
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh first floor
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
shahrzadyekta@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Hazrat Fatemeh
Full name of responsible person
Mohammad Moghami
Position
Masters of Nursing
Other areas of specialty/work
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh first floor
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
maghami_m70@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery Hazrat Fatemeh
Full name of responsible person
Dr. Shahrzad Yetatalab
Position
Assistant Professor
Other areas of specialty/work
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh first floor
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
shahrzadyekta@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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