NCT06200090

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,987

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (2)

  • Jefferson Scale of Empathy-Health Profession Student version (JSE-HPS)

    Baseline

  • Emotion Regulation Questionnaire (ERQ)

    Baseline

Interventions

No intervention

Eligibility Criteria

Age17 Years - 27 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Undergraduate nursing students from the five full-time levels

You may qualify if:

  • Undergraduate nursing students from the five full-time levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Al Mansurah, Dakhlyia, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Emotional RegulationBurnout, Psychological

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorStress, PsychologicalBehavioral Symptoms

Central Study Contacts

Ahmed Hashem El-Monshed, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

April 15, 2023

Primary Completion

October 30, 2023

Study Completion

February 1, 2024

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations