Assessments in Stress and Quality of Sleep/Life in Night-... | NCT02541747

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

NCT02541747

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Jul 12, 2016Estimated

Enrollment

77Actual

Phase

Phase 4

Conditions

Shift-Work Sleep Disorder

Interventions

massage

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jun 20, 2015

First Submission Date that Met QC Criteria

Sep 3, 2015

First Posted Date

Sep 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
massage	Active Comparator	massage for 30 min, once a week for 4 weeks	Behavioral: massage
control	No Intervention	Rest as control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
massage	Behavioral	massage	massage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
brain-derived neurotrophic factor		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pittsburgh sleep quality index (PSQI)	Psychological questionnaire	4 weeks
Depression score ( Zung's Self-Reported Depression Scale)	Psychological questionnaire- Zung's Self-Reported Depression Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Shift-Work Nurses and Staff

Exclusion Criteria:

Diabetes mellitus, cardiovascular disease and psychological disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wayne HH Sheu, MD, PhD	Taichung Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital		Taichang		407	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020178	Sleep Disorders, Circadian Rhythm

Ancestor Terms

ID	Term
D021081	Chronobiology Disorders
D009422	Nervous System Diseases
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided