EmpathyNCT06200090
Empathy and Emotional Regulation: A Multi-National Cross-Sectional Study
An observational study of Empathy and Emotional Regulation, run by Mansoura University at 1 site in Egypt.
Trial summary
Significant levels of psychological disorders and psychological distress among higher education students have been reported worldwide (Galdino et al., 2020), given that during these years there is a peak in prevalence of many mental disorders, particularly major depressive disorder (18.5% to 21.2%), generalized… Read more about this study
- Who is it for?
- Ages 17 to 27 years
- Conditions the study is for
- Empathy, Emotional Regulation, Burnout
- How many people
- 1,987 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 27 years
- All sexes
- Child, Adult
Study population: Undergraduate nursing students from the five full-time levels
Who may be able to join
- Undergraduate nursing students from the five full-time levels
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing
Al Mansurah, Dakhlyia, 35511
Ahmed Salah, PhD, +20 100 737 5871
About this study
Official title: Empathy and Emotional Regulation as Protective Factors Against Burnout Among Nursing Students: A Multi-National Cross-Sectional Study
Significant levels of psychological disorders and psychological distress among higher education students have been reported worldwide (Galdino et al., 2020), given that during these years there is a peak in prevalence of many mental disorders, particularly major depressive disorder (18.5% to 21.2%), generalized anxiety disorder (18.6% to 16.7%) and drug use disorder (45.9% to 59.8%). (Auerbach et al., 2018). Additionally, compared to other major students, medical school and nursing students experienced higher levels of burnout due to the complex curriculum and pressure for professional performance (Ling et al., 2014). Altogether, this evidence show that nursing students frequently experience psychological and emotional problems such as academic exhaustion, stress, depression, and anxiety during their four years of completing their degree (Hwang \& Kim, 2022).
To the best of our knowledge, this study is the first of its kind that addresses the issue of burnout and its relation to empathy and emotional regulation among nursing students at the middle east. Analyzing burnout syndrome among undergraduate nursing students may provide support for managers to implement prevention and management strategies in relation to the syndrome, in order to ensure health and well-being during the professional training process, as well as providing training for nurses engaged and prepared to provide quality care. Thus, this study aims to investigate the burnout syndrome among nursing students and its relation to empathy and emotional regulation.
- Conditions
- Empathy, Emotional Regulation, Burnout
- Being tested
- No intervention
- Medical subject headings
- Emotional Regulation, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory-Student Survey (MBI-SS)
The MBI-SS is made up of 15 items that constitute three scales: emotional exhaustion (EX; five items), cynicism (CY; four items), and academic efficacy (AE; six items). All the items are scored by using a seven-point Likert scale [from 0 (never) to 6 (always)]. High scores on EX, CY and low scores on AE were indicative of burnout (Academic efficacy items are reversed scored). According to the MBI-SS, high scores in the subscale of EX and CY indicate burnout, whereas low scores in AE indicate burnout.
Measured: Baseline
Secondary outcomes (2)
Jefferson Scale of Empathy-Health Profession Student version (JSE-HPS)
The JSE-HPS was developed with the preliminary psychometric data published in 2001 and is copyrighted by Thomas Jefferson University. The Jefferson Scale of Physician Empathy (JSPE) was originally developed to allow the measurement of empathy in physician cohorts (Hojat et al., 2001). However, given the importance of empathy as an undergraduate student trait, a number of research teams have adapted the JSPE for use with students from healthcare professions other than medicine (Fields et al., 2011; Fjortoft et al., 2011). The JSE-HPS consists of 20 items, which are responded on a seven-point Likert scale with 1 being strongly disagree and 7 being strongly agree for positively responded items and 1 being strongly agree and 7 being strongly disagree otherwise
Measured: Baseline
Emotion Regulation Questionnaire (ERQ)
Emotion Regulation Questionnaire (ERQ) (Gross \& John, 2003). This questionnaire is a 10-item self-report measure of two emotion regulation strategies: emotional suppression (ES; 4 items) and cognitive reappraisal (CR; 6 items). The participants responded on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). The total score ranged from 10 to 70 and the mean score was utilized, with a higher score presenting a higher level of emotion regulation strategies
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Apr 2023
- Primary completion30 Oct 2023
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpathyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,987 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hashem El-Monshed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200090
- Sponsor's protocol ID
- EmpathyMulti-National7
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathy and Emotional Regulation as Protective Factors Against Burnout Among Nursing Students: A Multi-National Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06200090
- Acronym / sponsor ID
- EmpathyMulti-National7
- Conditions
- Empathy, Emotional Regulation, Burnout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,987 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Significant levels of psychological disorders and psychological distress among higher education students have been reported worldwide (Galdino et al., 2020), given that during these years there is a peak in prevalence of many mental disorders, particularly major depressive disorder (18.5% to 21.2%), generalized anxiety disorder (18.6% to 16.7%) and drug use disorder (45.9% to 59.8%). (Auerbach et al., 2018). Additionally, compared to other major students, medical school and nursing students experienced higher levels of burnout due to the complex curriculum and pressure for professional performance (Ling et al., 2014). Altogether, this evidence show that nursing students frequently experience psychological and emotional problems such as academic exhaustion, stress, depression, and anxiety during their four years of completing their degree (Hwang \& Kim, 2022).
To the best of our knowledge, this study is the first of its kind that addresses the issue of burnout and its relation to empathy and emotional regulation among nursing students at the middle east. Analyzing burnout syndrome among undergraduate nursing students may provide support for managers to implement prevention and management strategies in relation to the syndrome, in order to ensure health and well-being during the professional training process, as well as providing training for nurses engaged and prepared to provide quality care. Thus, this study aims to investigate the burnout syndrome among nursing students and its relation to empathy and emotional regulation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 to 27 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Undergraduate nursing students from the five full-time levels
Key inclusion criteria (1 listed)
- Undergraduate nursing students from the five full-time levels
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Maslach Burnout Inventory-Student Survey (MBI-SS)
Time frame: Baseline
The MBI-SS is made up of 15 items that constitute three scales: emotional exhaustion (EX; five items), cynicism (CY; four items), and academic efficacy (AE; six items). All the items are scored by using a seven-point Likert scale [from 0 (never) to 6 (always)]. High scores on EX, CY and low scores on AE were indicative of burnout (Academic efficacy items are reversed scored). According to the MBI-SS, high scores in the subscale of EX and CY indicate burnout, whereas low scores in AE indicate burnout.
2 secondary outcomes
Jefferson Scale of Empathy-Health Profession Student version (JSE-HPS)
Time frame: Baseline
Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Empathy and Emotional Regulation, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hashem El-Monshed, Ph.D (+201009976771, ahmed_elmonshed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach Burnout Inventory-Student Survey (MBI-SS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.