NCT01011790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

November 9, 2009

Last Update Submit

February 3, 2012

Conditions

Keywords

Healing Rhythms™MeditationBiofeedbackStress

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

Stress Management Tool

EXPERIMENTAL

All subjects will use the Healing Rhythms™ meditation program for 4 weeks.

Behavioral: Healing Rhythms™ Meditation Program

Interventions

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.

Also known as: Wild Devine
Stress Management Tool

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects ≥ 18 years of age
  • Subjects that have given consent to participate
  • Subjects that have access to a home computer

You may not qualify if:

  • Subjects who are currently engaged in a routine meditative practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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):110-2. doi: 10.1016/j.explore.2010.12.004.

Study Officials

  • Susanne M. Cutshall, R.N., C.N.S.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
  • Brent A. Bauer, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

June 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations