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Sleep Enhancement Training Study for Novice Shiftworkers (SETS-novice)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00786266
First received: November 4, 2008
Last updated: June 22, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Shift-Work Sleep Disorder
 Behavioral: Sleep Enhancement Training System
Behavioral: NIOSH shiftwork booklet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sleep Enhancement Training Study for Novice Shiftworkers

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • actigraphy measures of sleep [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective measures of sleep and well-being [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NIOSH shiftwork booklet Behavioral: NIOSH shiftwork booklet
weekly readings about coping with shiftwork
Experimental: Sleep Enhancement Training System Behavioral: Sleep Enhancement Training System
4 week program of readings and relaxation programs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786266

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Christopher R Alsten, PhD Inner Health, Inc.
  More Information

No publications provided

Responsible Party: Christopher Alsten, PhD, Executive Vice President, Inner Health, Inc.
ClinicalTrials.gov Identifier: NCT00786266     History of Changes
Other Study ID Numbers: SETS-novice, R43NR010688
Study First Received: November 4, 2008
Last Updated: June 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
shift-work
sleep
nurse
relaxation

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
 Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases

ClinicalTrials.gov processed this record on June 18, 2013