WorkloadNCT04953429
Workload and Sleep Quality of Hospital Shift Nurses
An observational study of Workload and Sleep Quality, run by Peking University Third Hospital at 1 site in China.
Trial summary
A questionnaire survey was conducted to investigate the status of workload, sleep quality and the correlation between workload and sleep quality of shift nurses in Grade 3A hospitals in Beijing Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Workload, Sleep Quality
- What is being tested?
- workload
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Jan 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: nurses in a third-grade hospital in Beijing
Who may be able to join
- In service nurses who have obtained the nurse practice certificate of the people's Republic of China and have been registered;
- At present, he has been involved in shift work for more than 3 months, and the shifts include day shift, night shift and night shift;
- No obvious psychological or mental illness, such as depression; 4 volunteer to participate in this study.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: Correlation Between Workload and Sleep Quality of Shift Nurses in Top Three Hospitals in Beijing
A questionnaire survey was conducted to investigate the status of workload, sleep quality and the correlation between workload and sleep quality of shift nurses in Grade 3A hospitals in Beijing
Read the detailed description
The shift nurses in the top three hospitals in Beijing were included. According to the sample size calculation method of correlation coefficient in analytical research, the correlation coefficient between workload and sleep quality was obtained by consulting literature ρ=- 29, confidence level α= 0.05, β= Then the sample size calculation software pass 11.0 was used to calculate n = 99. Considering 20% sample loss, the final sample size was n = 119. The same interviewee (head nurse / nurse) was informed of the purpose and significance of this study by using the same guiding language. The head nurses were informed one-on-one by the implementer of the project and filled in the questionnaire after informed consent; The nurse survey was conducted by the project implementer himself to the head nurse of the Department for training. The head nurse informed the nurses of the Department with unified guidelines, and after informed consent, the head nurse sent the electronic questionnaire QR code to its wechat work group for filling in. The implementer of the project will check the questionnaire in time after the respondents fill in the questionnaire, and give timely feedback if there is any doubt. This study investigated the work load and sleep quality of nurses in the top three hospitals in Beijing; The survey included general information, workload and sleep quality. General information included gender, age, working years, professional title, education level, marriage and childbearing status, etc. The workload status includes mental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs. The sleep quality status of nurses in different shifts (day shift, night shift and night shift) included sleep disorder, difficulty in maintaining sleep, early wake-up, fatigue / sleepiness in working days and idle time in working days, etc.
- Conditions
- Workload, Sleep Quality
- Being tested
- workload
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workloadBehavioural
Mental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs of nursing work
| Study group | Role | What they receive |
|---|---|---|
| nurses | nurses in a third-grade hospital in Beijing Receives: Behavioral: workload |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality1
Sleep disorders
Measured: 1 month
sleep quality2
difficulty in maintaining sleep
Measured: 1 month
sleep quality3
early awakening
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2020
- Primary completion31 Aug 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorkloadStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baohua Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953429
- Sponsor's protocol ID
- M2020306
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Workload and Sleep Quality of Shift Nurses in Top Three Hospitals in Beijing
- ClinicalTrials.gov ID
- NCT04953429
- Acronym / sponsor ID
- M2020306
- Conditions
- Workload, Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 8 Jul 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.
A questionnaire survey was conducted to investigate the status of workload, sleep quality and the correlation between workload and sleep quality of shift nurses in Grade 3A hospitals in Beijing
Detailed description
The shift nurses in the top three hospitals in Beijing were included. According to the sample size calculation method of correlation coefficient in analytical research, the correlation coefficient between workload and sleep quality was obtained by consulting literature ρ=- 29, confidence level α= 0.05, β= Then the sample size calculation software pass 11.0 was used to calculate n = 99. Considering 20% sample loss, the final sample size was n = 119. The same interviewee (head nurse / nurse) was informed of the purpose and significance of this study by using the same guiding language. The head nurses were informed one-on-one by the implementer of the project and filled in the questionnaire after informed consent; The nurse survey was conducted by the project implementer himself to the head nurse of the Department for training. The head nurse informed the nurses of the Department with unified guidelines, and after informed consent, the head nurse sent the electronic questionnaire QR code to its wechat work group for filling in. The implementer of the project will check the questionnaire in time after the respondents fill in the questionnaire, and give timely feedback if there is any doubt. This study investigated the work load and sleep quality of nurses in the top three hospitals in Beijing; The survey included general information, workload and sleep quality. General information included gender, age, working years, professional title, education level, marriage and childbearing status, etc. The workload status includes mental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs. The sleep quality status of nurses in different shifts (day shift, night shift and night shift) included sleep disorder, difficulty in maintaining sleep, early wake-up, fatigue / sleepiness in working days and idle time in working days, etc.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nurses | – | Behavioral: workloadnurses in a third-grade hospital in Beijing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- nurses in a third-grade hospital in Beijing
Key inclusion criteria (3 listed)
- In service nurses who have obtained the nurse practice certificate of the people's Republic of China and have been registered;
- At present, he has been involved in shift work for more than 3 months, and the shifts include day shift, night shift and night shift;
- No obvious psychological or mental illness, such as depression; 4 volunteer to participate in this study.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| workloadMental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs of nursing work | Behavioural | nurses |
Primary outcome
sleep quality1
Time frame: 1 month
Sleep disorders
sleep quality2
Time frame: 1 month
difficulty in maintaining sleep
sleep quality3
Time frame: 1 month
early awakening
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 8 Jul 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Baohua Li principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Workload and Sleep Quality, run by Peking University Third Hospital at 1 site in China.
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 3 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 8 Jul 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 China. 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?
sleep quality1 (time frame: 1 month). The study lists 3 primary outcomes in all. 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 8 Jul 2021.