Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses
This study has been completed.
Sponsor:
Mayo Clinic
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
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 9, 2009 | ||||||
| Last Updated Date | February 3, 2012 | ||||||
| Start Date ICMJE | June 2008 | ||||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | Complete list of historical versions of study NCT01011790 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses | ||||||
| Official Title ICMJE | Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses: A Pilot Study | ||||||
| Brief 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. | ||||||
| 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 ICMJE | Interventional | ||||||
| Study Phase | Not Provided | ||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||
| Condition ICMJE | Stress | ||||||
| Intervention ICMJE | 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 |
||||||
| Study Arm (s) | Experimental: Stress Management Tool
All subjects will use the Healing Rhythms™ meditation program for 4 weeks.
Intervention: Behavioral: Healing Rhythms™ Meditation Program |
||||||
| Publications * | 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. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Enrollment ICMJE | 11 | ||||||
| Completion Date | July 2008 | ||||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
| Gender | Both | ||||||
| Ages | 18 Years to 90 Years (Adult, Senior) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01011790 | ||||||
| Other Study ID Numbers ICMJE | 08-002094 | ||||||
| Has Data Monitoring Committee | No | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | Brent A. Bauer, Mayo Clinic | ||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||
| Collaborators ICMJE | Wild Divine | ||||||
| Investigators ICMJE |
|
||||||
| Information Provided By | Mayo Clinic | ||||||
| Verification Date | February 2012 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||