Protocol summary

Study aim
Determining the Effect of Mindfulness Program on Compassion in Nursing Care in Undergraduate Nursing Students of Shahid Beheshti University of Medical Sciences.
Design
A quasi-experimental two-group study, with control and intervention groups, single-blind, randomized by coin toss, on 96 students.
Settings and conduct
At the first meeting with the students, the demographic information questionnaire and the standard patient compassion questionnaire are completed for both groups. Then, the mindfulness intervention program will be implemented for the students of the intervention department in the School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences. Two weeks after the end of the study, the standard patient compassion questionnaire was completed for the students of both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Undergraduate nursing students in internships of the third to sixth semesters 2. No students suffering from mental disorders Exclusion Requirement: Participation in research or similar training courses at the same time as the study.
Intervention groups
96 students will be enrolled in the study based on the inclusion criteria and available method and will be randomized into two intervention and control groups. In the first meeting with the students, the demographic information questionnaire and the standard patient compassion questionnaire are completed for both groups, and then the mindfulness intervention program is implemented for the students of the intervention group within eight weeks. Two weeks after the end of the study, the standard patient compassion questionnaire is completed for both groups.
Main outcome variables
Compassion for the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241017063399N1
Registration date: 2024-12-09, 1403/09/19
Registration timing: registered_while_recruiting

Last update: 2024-12-09, 1403/09/19
Update count: 0
Registration date
2024-12-09, 1403/09/19
Registrant information
Name
Mohadese Basirat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 2322
Email address
mohadesebasirat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-07, 1403/09/17
Expected recruitment end date
2025-02-15, 1403/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness program on compassion in nursing care among undergraduate nursing students of Shahid Beheshti University of Medical Sciences
Public title
"Investigating the effect of Mindfulness program on Compassion in nursing care"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Bachelor's degree nursing students studying in the third to sixth semester, who are taking clinical course units in the semester
Exclusion criteria:
The student has been diagnosed with any type of mental disorder Participating in similar research or training courses at the same time as the present study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, we use coin throws. Due to the nature of the students' class schedule, we divide the classes into two control and intervention groups, and in order to determine which class is in the control or intervention group, we use the coin toss method in this way: first we toss a coin for the first class, if the coin comes back, the group is controlled, and if it falls on the coin, the group intervenes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the first meeting with the students, after explaining the objectives of the study and obtaining informed written consent from them, they will be randomly assigned to one of the intervention and control groups. To prevent leakage of information between the two study groups, the information of the control group is first collected and completed, and then the intervention is implemented.
Placebo
Not used
Assignment
Parallel
Other design features
In the present study, we have two control and intervention groups. For the intervention group, mindfulness training will be done in 8 sessions, and in the control group, after the end of the study, a mindfulness training booklet will be given to the students.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.316

Health conditions studied

1

Description of health condition studied
Mindfulness, Compassion, Nursing Care, Nursing Students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Patient compassion score in patient compassion questionnaire
Timepoint
Before the start of the intervention and ten weeks after the start of the intervention
Method of measurement
Standard Patient Compassion Questionnaire ((Lee))

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first meeting with the students, the demographic information questionnaire and the standard patient compassion questionnaire are completed for the students of this group. Then, an 8-week mindfulness intervention program is implemented for them. Two weeks after the end of the study, the standard patient compassion questionnaire is completed for the students.
Category
N/A

2

Description
Control group: In the first meeting with the students, the demographic information questionnaire and the standard patient compassion questionnaire are completed for the students of this group. Then, ten weeks after the first meeting (two weeks after the end of the study on the students of the intervention group), the standard patient compassion questionnaire is completed for the students. At the end of the study, the mindfulness booklet will be given to the students of the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
School Of Nursing and Midwifery,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadese Basirat
Street address
Intersection of Valiasr St. and Niayesh Highway, in front of Rajaei Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5363
Email
mohadesebasirat@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadese Basirat
Position
Master's student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Hosein Hospital., Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 2322
Fax
Email
mohadesebasirat@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadese Basirat
Position
Master's student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Hosein Hospital., Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 2322
Fax
Email
mohadesebasirat@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohadese Basirat
Position
Master's student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Hosein Hospital., Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 2322
Fax
Email
mohadesebasirat@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 4 months after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can only be published for the purpose of knowing how to work and the realness of the samples and intervention
From where data/document is obtainable
Mohadese Basirat mohadesebasirat@sbmu.ac.ir mohadese.basirat@gmail.com
What processes are involved for a request to access data/document
Send message to personal or academic email
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