Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses

This study has been completed.
Sponsor:
Collaborator:
Wild Divine
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01011790
First received: November 9, 2009
Last updated: February 3, 2012
Last verified: February 2012

November 9, 2009
February 3, 2012
June 2008
July 2008   (final data collection date for primary outcome measure)
Assess the efficacy of a novel meditation program on stress, anxiety and quality of life (QOL) in nurses practicing in the hospital. Compare the level of stress, anxiety and QOL before and after a 4 week training period utilizing Healing Rhythms™. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011790 on ClinicalTrials.gov Archive Site
Evaluate feasibility of integrating a novel meditation program into an overall stress management program for nurses practicing in the hospital. Report overall satisfaction and identify challenges with the experience of the meditation program. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses
Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses: A Pilot Study

The purpose of this study is to assess a novel meditation program which is biofeedback reinforced (Healing Rhythms™) as a means to improving stress management in a population of nurses practicing in the hospital setting.

Stress is a common problem with significant ramifications for health. This is especially true in the workplace and particularly true for nurses practicing in a hospital environment. A number of factors (e.g. an aging population, the obesity epidemic, patients presenting with multi-system diseases, etc.) have dramatically increased the demands on hospital nurses in the past decade. This increased stress has potential ramifications at a personal level (e.g. increased risk of ill health) as well as an institutional (e.g. higher staff turnover). Meditation has been shown to be an effective tool for stress management. A self-directed, computer-guided meditation training program that can be pursued independently may be particularly useful for hospital nurses where scheduling challenges may preclude the use of scheduled classes. Healing Rhythms™ is a computer program that teaches meditation and uses biofeedback (heart rate variability and galvanic skin response) to reinforce the training.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stress
Behavioral: Healing Rhythms™ Meditation Program
The Healing Rhythms™ meditation program was chosen as the intervention for this study because it has a long history of use in the consumer market, it provides a dual-mode biofeedback which allows users to visually see their progress, and it provides an attractive and engaging user interface which is enjoyable to use. This is a critical factor as the research cited documents the importance of adherence in achieving optimal outcomes.
Other Name: Wild Devine
Experimental: Stress Management Tool
All subjects will use the Healing Rhythms™ meditation program for 4 weeks.
Intervention: Behavioral: Healing Rhythms™ Meditation Program
Cutshall SM, Wentworth LJ, Wahner-Roedler DL, Vincent A, Schmidt JE, Loehrer LL, Cha SS, Bauer BA. Evaluation of a biofeedback-assisted meditation program as a stress management tool for hospital nurses: a pilot study. Explore (NY). 2011 Mar-Apr;7(2):110-2. doi: 10.1016/j.explore.2010.12.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects ≥ 18 years of age
  • Subjects that have given consent to participate
  • Subjects that have access to a home computer

Exclusion Criteria:

  • Subjects who are currently engaged in a routine meditative practice
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011790
08-002094
No
Brent A. Bauer, Mayo Clinic
Mayo Clinic
Wild Divine
Principal Investigator: Susanne M. Cutshall, R.N., C.N.S. Mayo Clinic
Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic
Mayo Clinic
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP