Back to resultsAssessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
Primary Purpose
Shift-Work Sleep Disorder
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
massage
Sponsored by
About this trial
This is an interventional treatment trial for Shift-Work Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- Shift-Work Nurses and Staff
Exclusion Criteria:
- Diabetes mellitus, cardiovascular disease and psychological disorders
Sites / Locations
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
massage
control
Arm Description
massage for 30 min, once a week for 4 weeks
Rest as control
Outcomes
Primary Outcome Measures
brain-derived neurotrophic factor
Secondary Outcome Measures
Pittsburgh sleep quality index (PSQI)
Psychological questionnaire
Depression score ( Zung's Self-Reported Depression Scale)
Psychological questionnaire- Zung's Self-Reported Depression Scale
Anxiety score (Beck Anxiety Inventory)
Psychological questionnaire- Beck Anxiety Inventory
Heart rate variability
Cardiopulmonary functions
Metabolic syndrome (NCEP)
Third Report of the National Cholesterol Education Program (NCEP) criteria
VCAM-1
Cardiovascular risk and Inflammatory markers
Irisin
Cardiovascular risk and Inflammatory markers
circadian rhythm
orexin
Full Information
NCT ID
NCT02541747
First Posted
June 20, 2015
Last Updated
July 9, 2016
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02541747
Brief Title
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
Official Title
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
massage
Arm Type
Active Comparator
Arm Description
massage for 30 min, once a week for 4 weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
Rest as control
Intervention Type
Behavioral
Intervention Name(s)
massage
Intervention Description
massage
Primary Outcome Measure Information:
Title
brain-derived neurotrophic factor
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh sleep quality index (PSQI)
Description
Psychological questionnaire
Time Frame
4 weeks
Title
Depression score ( Zung's Self-Reported Depression Scale)
Description
Psychological questionnaire- Zung's Self-Reported Depression Scale
Time Frame
4 weeks
Title
Anxiety score (Beck Anxiety Inventory)
Description
Psychological questionnaire- Beck Anxiety Inventory
Time Frame
4 weeks
Title
Heart rate variability
Description
Cardiopulmonary functions
Time Frame
4 weeks
Title
Metabolic syndrome (NCEP)
Description
Third Report of the National Cholesterol Education Program (NCEP) criteria
Time Frame
4 weeks
Title
VCAM-1
Description
Cardiovascular risk and Inflammatory markers
Time Frame
4 weeks
Title
Irisin
Description
Cardiovascular risk and Inflammatory markers
Time Frame
4 weeks
Title
circadian rhythm
Description
orexin
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Shift-Work Nurses and Staff
Exclusion Criteria:
Diabetes mellitus, cardiovascular disease and psychological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne HH Sheu, MD, PhD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
City
Taichang
ZIP/Postal Code
407
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
We'll reach out to this number within 24 hrs