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Effect of empowerment program on moral distress and caregiving behaviors among intensive care unit nurses in end-of-life patients care

Protocol summary

Study aim
Determine the effect of an empowerment program on moral distress and caregiving behaviors among intensive care unit nurses in end-of-life patient care
Design
In this two-group randomized controlled trial study, first, 104 nurses will be selected through convenience sampling, and subsequently, they will be divided into control and intervention groups using the quadruple block randomization method.
Settings and conduct
This study will be a two-group randomized controlled trial involving 104 nursing practitioners in Hamadan. Within the intervention group, the researcher will conduct seven weekly sessions of the empowerment program, each lasting between 45 to 60 minutes. These sessions will cover topics such as recognising caring behaviors and moral distress, the ramifications of non-adherence, strategies to counteract unethical conduct, management of disruptive behaviors, mitigation of factors contributing to unethical practices, approaches to address moral distress, and subsequent evaluation. Assessments of moral distress and the caring behaviors of nurses will be conducted immediately after, and one month following, the final session of the empowerment program. The control group will not partake in any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate in the study, at least one year of work experience in intensive care units, and not having completed ethics-related courses in the past year. Exclusion criteria: unwillingness to continue participating in the study and absence of more than one session in the course classes.
Intervention groups
The researcher will hold Empowerment program sessions for the intervention group during 7 weekly sessions for 45 to 60 minutes. Control group: nurses in the control group will not receive any intervention.
Main outcome variables
Nurses's moral distress and caring behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211227053551N5
Registration date: 2024-06-08, 1403/03/19
Registration timing: prospective

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
ٰٰVahid Yousofvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3252 6339
Email address
v.yousofvand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of empowerment program on moral distress and caregiving behaviors among intensive care unit nurses in end-of-life patients care
Public title
Effect of empowerment program on moral distress and caregiving behaviors among nurses
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study At least one year of work experience in the intensive care unit Failure to pass courses related to ethics up to the last year
Exclusion criteria:
Unwillingness to continue participating in the study Absence of more than one session in the course classes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be done using the permutation block method. In such a way that first, four blocks of ABBA, AABB, ABAB, BBAA, BAAB and BABA will be produced in a number that covers the study sample and will be placed in envelopes. Then, when the nurse enters the study, one of the envelopes will be randomly selected, and the first four nurses will be assigned to two groups according to the desired block. This process will continue until the total number of samples is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.UMSHA.REC.1403.091

Health conditions studied

1

Description of health condition studied
Moral distress
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Caring behaviors of nurses
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Moral distress
Timepoint
Immediately, and one month after the intervention
Method of measurement
Corelli moral distress questionnaire

2

Description
Nurses caring behaviors
Timepoint
Immediately, and one month after the intervention
Method of measurement
Pattistelli nurses caring behaviors questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, the sessions of the empowerment program for nurses will be held by the researcher during 7 weekly sessions for 45 to 60 minutes. The empowerment program used in this research includes steps designed by the researcher using the moral calculation theory of Alvita K. Nathaniel in nursing. Evaluation of moral distress and caring behaviors of nurses will be done immediately and one month after the last empowerment session.
Category
N/A

2

Description
Control group: The control group will not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Haspital
Full name of responsible person
Mohammad Torabi
Street address
Shahid Beheshti Blvd., Besat hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 918 316 0499
Email
mtorabi316@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Torabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mtorabi316@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Torabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mtorabi316@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Torabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mtorabi316@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
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