Medical Students Well-being and AnxietyNCT04822454
Early Exposure of Medical Students to Night Shifts: Impact on Well-being and Anxiety
A study testing Night shift shadowing program in people with Medical Students Well-being and Anxiety, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Students Well-being and Anxiety
- What is being tested?
- Night shift shadowing program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2019to 1 Jun 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students of the class of 2021 at the Faculty of Medicine of Saint Joseph University in their fifth year (Med 2).
Who cannot join
- student who has already been on call during internships in Lebanon or abroad, as well as students in other medical years.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Medical Students Well-being and Anxiety
- Being tested
- Night shift shadowing program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night shift shadowing programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Night shift shadowing program | Experimental | Medical students who participated in a night shift shadowing program prior to their first official night shifts Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Students Well-being and AnxietyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Kerbage, St Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822454
- Sponsor's protocol ID
- StJosephBeirut
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exposure of Medical Students to Night Shifts: Impact on Well-being and Anxiety
- ClinicalTrials.gov ID
- NCT04822454
- Acronym / sponsor ID
- StJosephBeirut
- Conditions
- Medical Students Well-being and Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 30 Mar 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night shift shadowing program | Experimental | Other: Night shift shadowing programMedical students who participated in a night shift shadowing program prior to their first official night shifts |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Students of the class of 2021 at the Faculty of Medicine of Saint Joseph University in their fifth year (Med 2).
Key exclusion criteria (1 listed)
- student who has already been on call during internships in Lebanon or abroad, as well as students in other medical years.
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 |
|---|---|---|
| Night shift shadowing programOur 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. | Other | Night shift shadowing program |
Primary outcome
Questionnaire
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Medical Students Well-being and Anxiety
Not yet recruitingObservational study
Health Anxiety and Quality of Life Among Faculty of Medicine Students
Health Anxiety, Quality of Life
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night shift shadowing program in people with Medical Students Well-being and Anxiety, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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: finished, as of the sponsor's last update on 30 Mar 2021. 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 6 months). 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 30 Mar 2021.