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Clinical Trials/NCT01796054
NCT01796054
Completed
Not Applicable

Effectiveness of a Mind-body Stress Reduction Program for Nurses: A Randomized Controlled Study

The Cleveland Clinic1 site in 1 country360 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Stress
Sponsor
The Cleveland Clinic
Enrollment
360
Locations
1
Primary Endpoint
Burnout
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Randomized controlled trials of online mindfulness and relaxation programs have been studied in patients with conditions such as irritable bowel syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such programs given levels of job stress. This study will determine whether an online stress reduction program that incorporates meditation with and without concomitant group support reduces burnout among nurses, including emotional exhaustion and depersonalization. The proposed research study will utilize Stress Free Now, an online stress reduction program developed by Cleveland Clinic Wellness Institute.

Detailed Description

This is a randomized, controlled, single-center research study of an online intervention with peer group support to reduce stress in nurses. All participants will be assigned to the intervention or control groups by random number allocation. The duration of the intervention is 6 weeks; follow-up is at 6 and 24 weeks; the duration of the study is 6 months (24 weeks). Total individual participant time commitment will depend on particular intervention or control group assignment. Both intervention and control groups will be requested to complete a set of questionnaires at weeks 0, 6, and 24. The questionnaires will take an estimated 45 minutes to complete.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
August 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Linda Libertini

Research Coordinator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

  • be at least 18 years of age
  • work as a full-time or part-time nurse at Cleveland Clinic
  • have regular internet and email access and be willing and able to attend group support sessions
  • work at least one weekday during the week in order to attend orientation and/or group support sessions

Exclusion Criteria

  • participating in another stress reduction research study
  • pregnant, lactating, or planning to be pregnant in the next 6 months
  • hospitalized for depression in past 12 months
  • vacation time away from work for more than 1 week during the first 2 months of the study
  • current diagnosis of schizophrenia, other psychotic or bipolar disorder
  • other medial, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
  • unwilling or uninterested in participating in group sessions

Outcomes

Primary Outcomes

Burnout

Time Frame: 24 weeks

Measured by Maslach Burnout Inventory Human Services Survey

Secondary Outcomes

  • Emotional well-being(24 weeks)
  • Insomnia(24 weeks)
  • Mindfulness(24 weeks)
  • Intent to leave nursing(24 weeks)
  • Perceived stress(24 weeks)
  • Self-reported BMI(24 weeks)
  • Psychosomatic symptoms(24 weeks)

Study Sites (1)

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