- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541747
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
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CG14114
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.
Clinical Trials on Shift-Work Sleep Disorder
-
University of BergenRecruiting
-
VA Palo Alto Health Care SystemMerck Sharp & Dohme LLC; Stanford UniversityCompletedSleep Disorder, Shift-WorkUnited States
-
Henry Ford Health SystemCephalonCompletedShift Work Sleep DisorderUnited States
-
CephalonCompletedChronic Shift Work Sleep DisorderUnited States
-
University of OxfordRecruitingShift-work DisorderUnited Kingdom
-
Brigham and Women's HospitalCompletedShift-Work Sleep Disorder | Shift-Work Related Sleep DisturbanceUnited States
-
CephalonCompletedExcessive Sleepiness | Shift Work Sleep Disorder
-
Henry Ford Health SystemNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Henry Ford Health SystemAmerican Academy of Sleep MedicineRecruitingShift-work DisorderUnited States
Clinical Trials on massage
-
Chulalongkorn UniversityCompletedIschemic StrokeThailand
-
Mayo ClinicCompletedFatigue | Stress | Anxiety | TensionUnited States
-
TC Erciyes UniversityCompletedAbdominal Pain | Satisfaction, Patient | DistentionTurkey
-
muxing zhuRecruiting
-
Emre ErkalRecruiting
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedMusculoskeletal ManipulationsFrance
-
Mersin UniversityCompletedHemodialysis PatientsTurkey
-
Universitat Internacional de CatalunyaUnknown
-
São Paulo State UniversityFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of ValenciaCompletedHamstring ContracturesSpain