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

Stress Clinical Trial

Official title:

Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011790
• Other study ID #: 08-002094
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: February 3, 2012
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: February 2012
• Source: Mayo Clinic
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Wild Divine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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™.		4 Weeks	No
Secondary	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.		4 Weeks	No