Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors

July 9, 2016 updated by: Taichung Veterans General Hospital
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Night shift increases physical and psychological pressure, and even affects their sleep quality. This study aims to evaluate the effects of aroma massage to sleep quality of the nurses during night shift after life-style modification and/or aroma massage. The investigators adopt a Randomized Controlled Trial (RCT) in this study. The investigators expect aroma massage would improve the sleep quality during night shift.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

      • Taichang, Taiwan, 407
        • Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital

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

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shift-Work Nurses and Staff

Exclusion Criteria:

  • Diabetes mellitus, cardiovascular disease and psychological disorders

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: massage
massage for 30 min, once a week for 4 weeks
massage
No Intervention: control
Rest as control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
brain-derived neurotrophic factor
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh sleep quality index (PSQI)
Time Frame: 4 weeks
Psychological questionnaire
4 weeks
Depression score ( Zung's Self-Reported Depression Scale)
Time Frame: 4 weeks
Psychological questionnaire- Zung's Self-Reported Depression Scale
4 weeks
Anxiety score (Beck Anxiety Inventory)
Time Frame: 4 weeks
Psychological questionnaire- Beck Anxiety Inventory
4 weeks
Heart rate variability
Time Frame: 4 weeks
Cardiopulmonary functions
4 weeks
Metabolic syndrome (NCEP)
Time Frame: 4 weeks
Third Report of the National Cholesterol Education Program (NCEP) criteria
4 weeks
VCAM-1
Time Frame: 4 weeks
Cardiovascular risk and Inflammatory markers
4 weeks
Irisin
Time Frame: 4 weeks
Cardiovascular risk and Inflammatory markers
4 weeks
circadian rhythm
Time Frame: 4 weeks
orexin
4 weeks

Collaborators and Investigators

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

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

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 20, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 9, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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