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

February 3, 2012 updated by: Brent A. Bauer, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Wild Devine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Wild Divine

Investigators

  • Principal Investigator: Brent A. Bauer, M.D., Mayo Clinic
  • Principal Investigator: Susanne M. Cutshall, R.N., C.N.S., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-002094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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