Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses
| Tracking Information | |||||||||
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| 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. |
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| 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. |
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| 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 |
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| 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 |
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| 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 |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| 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 | ||||||||
| Responsible Party | Brent A. Bauer, Mayo Clinic | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | Wild Divine | ||||||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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