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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00786266
Other study ID # SETS-novice
Secondary ID R43NR010688
Status Completed
Phase Phase 1
First received November 4, 2008
Last updated June 22, 2010
Start date November 2008
Est. completion date May 2010

Study information

Verified date June 2010
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Enhancement Training System
4 week program of readings and relaxation programs
NIOSH shiftwork booklet
weekly readings about coping with shiftwork

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary actigraphy measures of sleep 6 weeks No
Secondary subjective measures of sleep and well-being 6 weeks No
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