Protocol summary
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Study aim
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Determining the Impact of Narrative Medicine Education (through the lens of nursing) on Self-Compassion and Understanding the Dimensions of Care in Nursing Students
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Design
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The present study will employ a quasi-experimental design with two groups: a control group and an experimental group, utilizing a pre-test/post-test format. Sampling will be conducted through convenience sampling. Simple randomization will be used for the allocation of intervention/control groups.
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Settings and conduct
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The research environment will be the School of Nursing and Midwifery and the hospitals affiliated with Shahid Beheshti University of Medical Sciences.
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Participants/Inclusion and exclusion criteria
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Population: Nursing students in their first or second semester who are taking the Nursing Principles and Skills Internship course for the first time.
Sample: First-semester nursing students at the School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, admitted in October 2024, groups A and B, who are taking the Nursing Principles and Skills Internship course for the first time and meet the entry criteria.
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Intervention groups
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Intervention Group consists of First-semester nursing students (in groups A or B: selected by random assignment) who will receive the Nursing Principles and Skills Internship training integrated with narrative medicine and Control Group will receive this course according to the standard curriculum of the school.
Both groups will consist of 8-12 members each. Initial information, self-compassion, and understanding the dimensions of care questionnaires will be completed once before the start of the internship and once at the end of the tenth (final) shift.
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Main outcome variables
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Self-Compassion; Understanding the Dimensions of Care
General information
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Reason for update
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Improving the randomization of groups
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230306057638N1
Registration date:
2024-08-15, 1403/05/25
Registration timing:
prospective
Last update:
2024-08-16, 1403/05/26
Update count:
1
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Registration date
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2024-08-15, 1403/05/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-11-21, 1403/09/01
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Expected recruitment end date
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2025-02-18, 1403/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of narrative medicine education (through the lens of nursing) on self-compassion and understanding the dimensions of care in nursing students
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Public title
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The effect of narrative medicine education in nursing students
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ability to communicate in Persian.
Taking the course on Principles and Skills of Nursing (theoretical and practical) and the related internship for the first time in course selection (without prior experience in course completion).
Exclusion criteria:
Students who have had or currently have any duration of experience in clinical therapeutic work.
Students who, after the initiation of the research process, refuse to complete the questionnaires at any stage or complete them incompletely.
Students who completed fewer than 9 out of 10 internship shifts in the hospital due to justified or unjustified absences.
Students who change their major, or resign from their academic program during their course of study.
Students who pass away during their course of study.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Students admitted to the Bachelor of Nursing program for the academic year 1403 (2024) will be divided into two relatively balanced classes, A and B, upon their initial enrollment at the university. This division will be based on the arrangement of the school, and the research team will adhere to the guidelines established by the esteemed educational unit.
The allocation of individuals to intervention and control groups will be conducted through simple randomization in three stages:
1. First Stage of Randomization: The assignment of intervention/control to classes A and B will be determined by a coin toss. (Rationale: This is to reduce the exposure of students in the intervention groups to those in the control groups.)
2. Second Stage: Thirty students from each group, A and B, will be randomly selected independently. (In total, 60 students will be involved, but the groups will not be mixed.) (Rationale: This ensures that all students from classes A and B can potentially participate in the study.)
3. Third Stage: Each of the selected students from groups A and B, whose allocation to intervention and control groups has now been determined, will be randomly divided into groups of 8 to 12 for clinical training in the hospital. (In this stage, due to the importance of fostering a friendly atmosphere in team-based clinical education, efforts will be made to accommodate student preferences as much as possible.)
Gender balance (male/female) will be maintained throughout all stages of randomization.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the educational nature of the study, only the statistical analyst will be blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-08-05, 1403/05/15
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1403.127
Health conditions studied
1
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Description of health condition studied
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Internship will take place in the internal-surgery departments of hospitals, focusing on patients with internal and surgical issues.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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self-compassion
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Timepoint
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Before the intervention, after the end of the tenth (last) internship shift.
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Method of measurement
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Neff self-compassion questionnaire (2003)
2
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Description
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Caring Dimensions Inventory
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Timepoint
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Before the intervention, after the end of the tenth (last) internship shift.
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Method of measurement
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Caring Dimensions Inventory-35: CDI-35_Watson
Intervention groups
1
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Description
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Intervention group: The main theoretical topics of the intervention group training will include: What is narrative medicine? (Origins and sources of narrative medicine, filling the gaps in healthcare, characteristics of narrative in medical sciences), the stories of illnesses (recounting life stories, patient-body-self), development of narrative competencies (close reading, attention-representation-dependence, parallel diagrams), and the benefits of narrative medicine (testifying, bioethical considerations in narrative medicine, narrative perspectives for healthcare). Initially, theoretical concepts will be explored using methods such as brainstorming and flipped classrooms. This will be followed by practical training through role-playing, observation and critique of related films and literature, group discussions, team-based learning, and scenario-based training. Finally, education will take place at the bedside of patients. The goal is to practice and learn the application of narrative medicine and its components in relation to real patients. To foster intimacy and create a pleasant educational atmosphere while avoiding monotony, diverse teaching methods will be employed, alongside additional strategies such as learning cafés or working breakfasts. It is understood that short-term feedback will be provided to students during clinical exercises. Assessment will be cumulative and progressive, with instruction conducted by both the supervising instructor and the researcher (student).
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Category
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Treatment - Other
2
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Description
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Control group: In the control group, trained instructors will be responsible for conducting the training according to the routine lesson plan of the school. In all groups of the control group, a pre-test will be administered at the beginning of the first day of the internship, and a post-test will be completed by the end of the tenth day.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The study protocol, informed consent forms, and the study report will be published in full.
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When the data will become available and for how long
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Once the article has been submitted to the journal and indexed in the appropriate databases, it will be made accessible.
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To whom data/document is available
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Without limitation.
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Under which criteria data/document could be used
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There are no restrictions, provided that copyright is respected and the source is cited."
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From where data/document is obtainable
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Email to the first author: Ms. Negin Farid
Email: neginfarid.79@gmail.com
In case of no response:
n.farid@sbmu.ac.ir
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What processes are involved for a request to access data/document
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In order to access the protocol of the researcher's version and the study report, it is necessary for the applicant to email Ms. Farid with his/her details, including first and last name, affiliation, reason for needing the file, and his/her contact number. If allowed by the research team and under the condition of respecting the copyright, it will be available to them within a week.
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Comments
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