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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01047917
Other study ID # 07-006601
Secondary ID
Status Completed
Phase N/A
First received January 11, 2010
Last updated January 4, 2012
Start date March 2008
Est. completion date April 2008

Study information

Verified date January 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 test a simple meditation program that is easy to learn; inexpensive; easy to practice; non-religion based; and has wide applicability to multiple medical conditions. This program has been developed by the Complementary and Integrative Medicine Program at the Mayo Clinic.


Description:

Stress is a ubiquitous problem and a mediator of symptoms for a variety of medical conditions. Most medical diagnoses, procedures, and physician visits are associated with considerable stress. Excessive stress is associated with adverse medical outcomes, unhealthy coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. No specific pharmacologic treatment is available for treating stress. Further, it is often difficult or impossible to change the reality of circumstances causing stress in an individual. Thus increasing individual coping mechanisms and ability of a person to handle stress, rather than changing the stressors itself, might be a more feasible approach towards reducing stress.

Meditation is a widely used and increasingly popular intervention that positively affects the individual at cognitive, physical, emotional, behavioral, and spiritual levels. A practice of meditation has been shown to reduce symptoms of stress and improve overall quality of life. Several meditation programs exist, however most are limited by considerable expense, need for elaborate training, lack of widespread availability, or incorporation of ideas and practices unique to a particular culture.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18 years of age

- Good general health

- Access to a DVD player

- Provided with, understand, and have signed the informed consent

Exclusion Criteria:

- Are currently using (at the time of enrollment) antipsychotics or recently (< 3 months) started on antidepressants. Patients on stable dose of antidepressant (for = 3 months) will be allowed.

- Have a lifetime history of schizophrenia

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Meditation DVD
Participants will undergo a one-hour group instruction session in meditation held by Dr. Amit Sood. Participants will then receive a DVD to practice the intervention at home daily for a total of 4 weeks. The DVD will have 3 different programs of 5, 15, and 30 minutes each loaded on it with a menu option to choose one of the programs.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Prasad K, Wahner-Roedler DL, Cha SS, Sood A. Effect of a single-session meditation training to reduce stress and improve quality of life among health care professionals: a "dose-ranging" feasibility study. Altern Ther Health Med. 2011 May-Jun;17(3):46-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the feasibility of incorporating a 4-week innovative meditation program into the daily activities of healthy Mayo Clinic employees for improving stress. 4 Weeks No
Secondary To assess the effect of a 4-week program of meditation on perceived stress and overall quality of life compared to baseline. 4 Weeks No
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