Protocol summary

Study aim
Determining of the effect of using spiritual care on the moral distress in nursing students
Design
Field trial with control group, with parallel, randomized groups, 80 people
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, complete the demographic characteristics checklist and the moral distress in students questionnaire. In the intervention group, Students will be divided into groups of 5 to 10 people. Interventions in 3 sessions for 45 to 60 minutes during 3 weeks are based on a similar study by the researcher. No training will be given to the control group. After completing the training, complete the moral distress in students questionnaire. The place of training is the classrooms of nursing students.
Participants/Inclusion and exclusion criteria
Admission requirements: Willingness and informed consent to participate in the study, Obtaining a score of 72 or less in the students' moral distress questionnaire. Conditions of non-entry: Previous participation in studies similar to the current research in less than 6 months.
Intervention groups
Intervention group: In this group, Students will be divided into groups of 5 to 10 people. Interventions in 3 sessions for 45 to 60 minutes during 3 weeks are based on a similar study by the researcher. Control group: non-intervention: this training group will not be given.
Main outcome variables
Moral distress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046044N2
Registration date: 2024-08-19, 1403/05/29
Registration timing: prospective

Last update: 2024-08-19, 1403/05/29
Update count: 0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Mohammadsajjad Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5242 1065
Email address
sajjad.mousavi2512@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using spiritual care on the moral distress in nursing students
Public title
Investigating the effect of using spiritual care on the moral distress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nursing undergraduate student Ability to communicate and answer questions Consent to participate in the study and sign the informed consent form Obtaining a score of 72 or less in the students' moral distress questionnaire
Exclusion criteria:
Not wanting to continue participating in the study Previous participation in studies similar to the current research in less than 6 months Lack of inclusion criteria
Age
From 18 years old to 40 years old
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
Eligible participants will be selected through convenience sampling and will be assigned to one of two intervention and control groups through random block allocation. The presence of two groups of blocks of size 2, 4 and 6 will be used. For example, in the case where the block size is 2, we will have two states AB and BA (A and B are intervention and control groups). The online site will be used for the purpose of sequence and concealment. A specific randomization code will be generated and a list of block random allocation will be compiled. After fully explaining and explaining the objectives of the study, eligible research samples will be selected and based on the time priority of referrals, a code will be assigned to each of them, and by matching that number with the random block allocation list, the patients participating in the research, They will be assigned to one of the intervention and control groups. This process will continue until the estimated sample size 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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-07-24, 1403/05/03
Ethics committee reference number
IR.YUMS.REC.1403.067

Health conditions studied

1

Description of health condition studied
The moral distress in nursing students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Moral distress
Timepoint
The level of the moral distress in nursing students at the beginning of the study (before the intervention) and after the intervention
Method of measurement
The moral distress in students questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, before the intervention, first in the stage before forming the group, with each person with the desired conditions, about the purpose of the research, the rules and regulations of the group, the place and time of the meetings, the duration of the group, the number of meetings and the length The duration of each meeting, duties and responsibilities of people will be discussed. The interventions will be done by the researcher in a group and in compliance with health protocols. People will be divided into groups of 5 to 10 people. Interventions will be conducted in 3 sessions for 45 to 60 minutes during 3 weeks based on the same study and according to the protocol.
Category
Lifestyle

2

Description
Control group: non-intervention: this training group will not be given.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences - Faculty of Nursing
Full name of responsible person
MohammadSajjad Mousavi
Street address
Faculty of Nursing, Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital, Yasuj, Kohgiloyeh and Boyerahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Fax
+98 74 3333 7230
Email
info@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
research@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
MohammadSajjad Mousavi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
City
Bandar-e-Mahshahr
Province
Khouzestan
Postal code
6354169401
Phone
+98 61 5242 1065
Email
sajjad.mousavi2512@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
MohammadSajjad Mousavi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
City
Bandar-e-Mahshahr
Province
Khouzestan
Postal code
6354169401
Phone
+98 61 5242 1065
Email
sajjad.mousavi2512@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
MohammadSajjad Mousavi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
City
Bandar-e-Mahshahr
Province
Khouzestan
Postal code
6354169401
Phone
+98 61 5242 1065
Email
sajjad.mousavi2512@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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