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

Shift-Work Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541747
• Other study ID #: CG14114
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2015
• Last updated: July 9, 2016
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Shift-Work Nurses and Staff

Exclusion Criteria:

• Diabetes mellitus, cardiovascular disease and psychological disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Shift-Work Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Behavioral:
• massage
massage

Locations

Country	Name	City	State
Taiwan	Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital	Taichang

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain-derived neurotrophic factor		4 weeks	No
Secondary	Pittsburgh sleep quality index (PSQI)	Psychological questionnaire	4 weeks	No
Secondary	Depression score ( Zung's Self-Reported Depression Scale)	Psychological questionnaire- Zung's Self-Reported Depression Scale	4 weeks	No
Secondary	Anxiety score (Beck Anxiety Inventory)	Psychological questionnaire- Beck Anxiety Inventory	4 weeks	No
Secondary	Heart rate variability	Cardiopulmonary functions	4 weeks	No
Secondary	Metabolic syndrome (NCEP)	Third Report of the National Cholesterol Education Program (NCEP) criteria	4 weeks	No
Secondary	VCAM-1	Cardiovascular risk and Inflammatory markers	4 weeks	No
Secondary	Irisin	Cardiovascular risk and Inflammatory markers	4 weeks	No
Secondary	circadian rhythm	orexin	4 weeks	No