Back to resultsSleep Enhancement Training Study for Novice Shiftworkers (SETS-novice)
Primary Purpose
Shift-Work Sleep Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sleep Enhancement Training System
NIOSH shiftwork booklet
Sponsored by
About this trial
This is an interventional prevention trial for Shift-Work Sleep Disorder focused on measuring shift-work, sleep, nurse, relaxation
Eligibility Criteria
Inclusion Criteria:
- English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months
Exclusion Criteria:
- > 6 months experience working night-shift
- current diagnosis of sleep disorder or affective illness
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
NIOSH shiftwork booklet
Sleep Enhancement Training System
Arm Description
Outcomes
Primary Outcome Measures
actigraphy measures of sleep
Secondary Outcome Measures
subjective measures of sleep and well-being
Full Information
NCT ID
NCT00786266
First Posted
November 4, 2008
Last Updated
June 22, 2010
Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00786266
Brief Title
Sleep Enhancement Training Study for Novice Shiftworkers
Acronym
SETS-novice
Official Title
Sleep Enhancement Training Study for Novice Shiftworkers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder
Keywords
shift-work, sleep, nurse, relaxation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIOSH shiftwork booklet
Arm Type
Active Comparator
Arm Title
Sleep Enhancement Training System
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Sleep Enhancement Training System
Intervention Description
4 week program of readings and relaxation programs
Intervention Type
Behavioral
Intervention Name(s)
NIOSH shiftwork booklet
Intervention Description
weekly readings about coping with shiftwork
Primary Outcome Measure Information:
Title
actigraphy measures of sleep
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
subjective measures of sleep and well-being
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months
Exclusion Criteria:
> 6 months experience working night-shift
current diagnosis of sleep disorder or affective illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Alsten, PhD
Organizational Affiliation
Inner Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sleep Enhancement Training Study for Novice Shiftworkers
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