NCT04822454

Brief Summary

This is an interventional study assessing the impact of 'shadowing night shifts' early during medical school, on the wellbeing and level of anxiety of a students during their first official night shifts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    After the shadowing program is completed, both groups of medical students (those who participated in the shadowing program and those who did not), have to fill a questionnaire that assesses their wellbeing and level of anxiety regarding their first official night shifts. Our primary outcome is to evaluate the impact of the shadowing program on medical students well-being and their level of anxiety.

    6 months

Study Arms (2)

Night shift shadowing program

EXPERIMENTAL

Medical students who participated in a night shift shadowing program prior to their first official night shifts

Other: Night shift shadowing program

No night shift shadowing program

NO INTERVENTION

Medical students who did not participate in the night shift shadowing program prior to their first official night shifts

Interventions

Our population, made up of 70 students, was divided into two randomly randomized groups: 31 (44.3%) had five night shift shadowing duty prior to their first official night shifts, and 39 (55.7%) did not participate in the shadowing program.

Night shift shadowing program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students of the class of 2021 at the Faculty of Medicine of Saint Joseph University in their fifth year (Med 2).

You may not qualify if:

  • student who has already been on call during internships in Lebanon or abroad, as well as students in other medical years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph University

Beirut, N/A (n/a), 1003, Lebanon

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PGY-1 Resident of Internal Medicine

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

January 1, 2019

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations