Apples in Night Shift

November 28, 2024 updated by: Li Rong, Peking University Third Hospital

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Doctors who have a night shift in the emergency department of gynaecology with at least two weeks experience.

Exclusion Criteria:

Doctors who refuse to join the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: no apple group
No apples during night shift
Procedure: no apple group
No apples during night shift
Experimental: apple group
Doctors will bring apples during night shift
Procedure: apple group
Doctors will bring apples during night shift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients
Time Frame: from 5pm on the Randomization day to 8am on the next day
Number of patients during the night shift
from 5pm on the Randomization day to 8am on the next day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of night shifts
Time Frame: from 5pm on the Randomization day to 8am on the next day
Overall evaluation of night shifts by doctors (Good, Average, Poor)
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
Admissions of emergency patients during the night shift randomized.
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
Number of patients who experience emergency surgery during the night shift.
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
Number of patients who need emergency uterine evacuation during the night shift.
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
The number of patients needs to be checked by a senior doctor
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
The time (hours) of the doctor's break.
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
The number of people who need to be admitted to the emergency room
from 5pm on the Randomization day to 8am on the next day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APPLE study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all night shift data

IPD Sharing Time Frame

The data will be available when they have been published in journals.

IPD Sharing Access Criteria

Please contact investigator Kai-Lun Hu. hukailun@bjmu.edu.cn

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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