NCT06542510

Brief Summary

To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart. Thirty-five female nurses, with a mean age of 28.7 years (range 21.0-37.0 years), participated in this study. On the first and second mornings after a night shift, the nurses performed the 6MWT. During the test, electrocardiogram (ECG) signals, blood pressure, and walking distance were recorded simultaneously.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 5, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

heart rate variability; night shift; autonomic nervous system; six-minute walk test; nurses

Outcome Measures

Primary Outcomes (1)

  • Delta HRV during the 6MWT

    On the first and second mornings after a night shift, the nurses performed the 6MWT.During the test, electrocardiogram (ECG) signals was recorded simultaneously.

    18 minutes

Interventions

working night shift

Also known as: night shift

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatient self-report
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The participants were nurses from Nanfang Hospital of Southern Medical University who worked ward shifts. The nurses in this study had one night shift every 5-10 days, from 00:00 a.m. to 8:00 a.m., followed by 2-3 days off.

You may not qualify if:

  • (ⅰ) having children at home who require night care; (ⅱ) current pregnancy; (ⅲ) engaging in activities that significantly impact heart rate, such as sexual activity, 24 hours before and 24 hours after working night shifts; (ⅳ) history of thyroid dysfunction, hypertension, diabetes, coronary heart disease, etc.; (ⅴ) experiencing upper respiratory tract infection, fever, cough, diarrhea, or other illnesses within 1 week before the planned enrollment; (ⅵ) consuming coffee or strong tea, smoking, drinking alcohol, or using other substances that affect heart rate 3 days before the planned enrollment; (ⅶ) taking β-receptor blockers, sleeping pills, psychotropic drugs, or other medications that affect heart rate; and (ⅷ) judged by the investigator to be unsuitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

  • Zhan T, Wei X, Zhang Z, Shi Z, Xie H, Ma X, Pan S, Zha D. The impact of working night shifts on cardiac autonomic nervous regulation during the six-minute walk test in nurses. BMC Nurs. 2024 Dec 18;23(1):907. doi: 10.1186/s12912-024-02563-y.

MeSH Terms

Interventions

Shift Work Schedule

Intervention Hierarchy (Ancestors)

Personnel Staffing and SchedulingPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 7, 2024

Study Start

January 30, 2024

Primary Completion

April 15, 2024

Study Completion

April 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The data of the study are available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL

Locations