Night WorkNCT06714422
Apples in Night Shift
A study testing apple group and no apple group in people with Night Work, run by Peking University Third Hospital.
Trial summary
Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Night Work
- What is being tested?
- apple group and no apple group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Doctors who have a night shift in the emergency department of gynaecology with at least two weeks experience.
Who cannot join
- Doctors who refuse to join the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Should Doctors Bring an Apple to Have a More Relaxed Night Shift?: a Single Center, Open Label, Randomized Trial
Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. There are various health interventions for night shift doctors, one of which is an interesting practice of carrying an apple as a symbol of the "night shift deity" to relieve anxiety and improve work efficiency. Although this behavior is not supported by sufficient scientific evidence, it has become a common habit among some doctors during night shifts due to its simplicity, low risk, and ritualistic nature.
Objective: To assess whether carrying an apple during night shifts can significantly reduce fatigue, decrease work intensity, and enhance work experience for emergency doctors.
Read more
Design: Single-center, open-label, randomized controlled trial.
Participants: several doctors with a total of 60 emergency working night shifts.
Primary Outcome: Average number of patients per night shift.
Sample Size: The study plans to recruit several doctors with a total of 60 emergency night shifts and randomly assign them to the experimental group and the control group. One doctor can be randomized for many times.
Read the detailed description
Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. There are various health interventions for night shift doctors, one of which is an interesting practice of carrying an apple as a symbol of the "night shift deity" to relieve anxiety and improve work efficiency. Although this behavior is not supported by sufficient scientific evidence, it has become a common habit among some doctors during night shifts due to its simplicity, low risk, and ritualistic nature.
Objective: To assess whether carrying an apple during night shifts can significantly reduce fatigue, decrease work intensity, and enhance work experience for emergency doctors.
Design: Single-center, open-label, randomized controlled trial.
Participants: several doctors with a total of 60 emergency working night shifts.
Primary Outcome: Average number of patients per night shift.
Sample Size: The study plans to recruit several doctors with a total of 60 emergency night shifts and randomly assign them to the experimental group and the control group. One doctor can be randomized for many times.
- Conditions
- Night Work
- Being tested
- apple group, no apple group
- Keywords
- night shift, apple, doctor, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apple groupProcedure or surgery
Doctors will bring apples during night shift
no apple groupProcedure or surgery
No apples during night shift
| Study group | Role | What they receive |
|---|---|---|
| no apple group | Active comparator | No apples during night shift Receives: Procedure: no apple group |
| apple group | Experimental | Doctors will bring apples during night shift Receives: Procedure: apple group |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients
Number of patients during the night shift
Measured: from 5pm on the Randomization day to 8am on the next day
Secondary outcomes (7)
Evaluation of night shifts
Overall evaluation of night shifts by doctors (Good, Average, Poor)
Measured: from 5pm on the Randomization day to 8am on the next day
Emergency admissions
Admissions of emergency patients during the night shift randomized.
Measured: from 5pm on the Randomization day to 8am on the next day
Emergency surgery number
Number of patients who experience emergency surgery during the night shift.
Measured: from 5pm on the Randomization day to 8am on the next day
Emergency uterine evacuation number
Number of patients who need emergency uterine evacuation during the night shift.
Measured: from 5pm on the Randomization day to 8am on the next day
Complicated patients number
The number of patients needs to be checked by a senior doctor
Measured: from 5pm on the Randomization day to 8am on the next day
Doctor's break time
The time (hours) of the doctor's break.
Measured: from 5pm on the Randomization day to 8am on the next day
Number of patients admitted to emergency room
The number of people who need to be admitted to the emergency room
Measured: from 5pm on the Randomization day to 8am on the next day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Night WorkStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Rong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714422
- Sponsor's protocol ID
- APPLE study
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all night shift data
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Doctors Bring an Apple to Have a More Relaxed Night Shift?: a Single Center, Open Label, Randomized Trial
- ClinicalTrials.gov ID
- NCT06714422
- Acronym / sponsor ID
- APPLE study
- Conditions
- Night Work
- Keywords
- night shift, apple, doctor, emergency department
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 3 Dec 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.
Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. There are various health interventions for night shift doctors, one of which is an interesting practice of carrying an apple as a symbol of the "night shift deity" to relieve anxiety and improve work efficiency. Although this behavior is not supported by sufficient scientific evidence, it has become a common habit among some doctors during night shifts due to its simplicity, low risk, and ritualistic nature.
Objective: To assess whether carrying an apple during night shifts can significantly reduce fatigue, decrease work intensity, and enhance work experience for emergency doctors.
Design: Single-center, open-label, randomized controlled trial.
Participants: several doctors with a total of 60 emergency working night shifts.
Primary Outcome: Average number of patients per night shift.
Sample Size: The study plans to recruit several doctors with a total of 60 emergency night shifts and randomly assign them to the experimental group and the control group. One doctor can be randomized for many times.
Detailed description
Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. There are various health interventions for night shift doctors, one of which is an interesting practice of carrying an apple as a symbol of the "night shift deity" to relieve anxiety and improve work efficiency. Although this behavior is not supported by sufficient scientific evidence, it has become a common habit among some doctors during night shifts due to its simplicity, low risk, and ritualistic nature.
Objective: To assess whether carrying an apple during night shifts can significantly reduce fatigue, decrease work intensity, and enhance work experience for emergency doctors.
Design: Single-center, open-label, randomized controlled trial.
Participants: several doctors with a total of 60 emergency working night shifts.
Primary Outcome: Average number of patients per night shift.
Sample Size: The study plans to recruit several doctors with a total of 60 emergency night shifts and randomly assign them to the experimental group and the control group. One doctor can be randomized for many times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no apple group | Active comparator | Procedure: no apple groupNo apples during night shift |
| apple group | Experimental | Procedure: apple groupDoctors will bring apples during night shift |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Doctors who have a night shift in the emergency department of gynaecology with at least two weeks experience.
Key exclusion criteria (1 listed)
- Doctors who refuse to join the study
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 |
|---|---|---|
| apple groupDoctors will bring apples during night shift | Procedure or surgery | apple group |
| no apple groupNo apples during night shift | Procedure or surgery | no apple group |
Primary outcome
number of patients
Time frame: from 5pm on the Randomization day to 8am on the next day
Number of patients during the night shift
7 secondary outcomes
Evaluation of night shifts
Time frame: from 5pm on the Randomization day to 8am on the next day
Emergency admissions
Time frame: from 5pm on the Randomization day to 8am on the next day
Emergency surgery number
Time frame: from 5pm on the Randomization day to 8am on the next day
Emergency uterine evacuation number
Time frame: from 5pm on the Randomization day to 8am on the next day
Complicated patients number
Time frame: from 5pm on the Randomization day to 8am on the next day
Doctor's break time
Time frame: from 5pm on the Randomization day to 8am on the next day
Number of patients admitted to emergency room
Time frame: from 5pm on the Randomization day to 8am on the next day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Yes. all night shift data
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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.
Questions about this trial
What is this clinical trial studying?
A study testing apple group and no apple group in people with Night Work, run by Peking University Third Hospital.
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: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai-Lun Hu, MD (86-15901575271, hukailun@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients (time frame: from 5pm on the Randomization day to 8am on the next day). 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 3 Dec 2024.