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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04953429
Other study ID # M2020306
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date January 31, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date January 31, 2021
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. In service nurses who have obtained the nurse practice certificate of the people's Republic of China and have been registered; 2. 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; 3. No obvious psychological or mental illness, such as depression; 4 volunteer to participate in this study. Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
workload
Mental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs of nursing work

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary sleep quality1 Sleep disorders 1 month
Primary sleep quality2 difficulty in maintaining sleep 1 month
Primary sleep quality3 early awakening 1 month
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