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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541747
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Brief Summary:
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.

Condition or disease Intervention/treatment Phase
Shift-Work Sleep Disorder Behavioral: massage Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: massage
massage for 30 min, once a week for 4 weeks
Behavioral: massage
massage

No Intervention: control
Rest as control



Primary Outcome Measures :
  1. brain-derived neurotrophic factor [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Pittsburgh sleep quality index (PSQI) [ Time Frame: 4 weeks ]
    Psychological questionnaire

  2. Depression score ( Zung's Self-Reported Depression Scale) [ Time Frame: 4 weeks ]
    Psychological questionnaire- Zung's Self-Reported Depression Scale

  3. Anxiety score (Beck Anxiety Inventory) [ Time Frame: 4 weeks ]
    Psychological questionnaire- Beck Anxiety Inventory

  4. Heart rate variability [ Time Frame: 4 weeks ]
    Cardiopulmonary functions

  5. Metabolic syndrome (NCEP) [ Time Frame: 4 weeks ]
    Third Report of the National Cholesterol Education Program (NCEP) criteria

  6. VCAM-1 [ Time Frame: 4 weeks ]
    Cardiovascular risk and Inflammatory markers

  7. Irisin [ Time Frame: 4 weeks ]
    Cardiovascular risk and Inflammatory markers

  8. circadian rhythm [ Time Frame: 4 weeks ]
    orexin



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Shift-Work Nurses and Staff

Exclusion Criteria:

  • Diabetes mellitus, cardiovascular disease and psychological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541747


Locations
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Taiwan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichang, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Wayne HH Sheu, MD, PhD Taichung Veterans General Hospital

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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT02541747    
Other Study ID Numbers: CG14114
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases