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
  Purpose

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.


Condition Intervention
Stress
Behavioral: Healing Rhythms™ Meditation Program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress Management Tool
All subjects will use the Healing Rhythms™ meditation program for 4 weeks.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011790

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Wild Divine
Investigators
Principal Investigator: Susanne M. Cutshall, R.N., C.N.S. Mayo Clinic
Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic
  More Information

Publications:
Responsible Party: Brent A. Bauer, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01011790     History of Changes
Other Study ID Numbers: 08-002094
Study First Received: November 9, 2009
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Healing Rhythms™
Meditation
Biofeedback
Stress

ClinicalTrials.gov processed this record on April 15, 2014