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Does the Relaxation Response Inhibit Acute Stress?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179595
First Posted: September 16, 2005
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
  Purpose

The purposes of this study are:

  1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
  2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.


Condition Intervention Phase
Healthy Behavioral: relaxation response- meditation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Health Services Research
Official Title: Does the Relaxation Response Inhibit Acute Stress?

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.

Secondary Outcome Measures:
  • To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Estimated Enrollment: 140
Study Start Date: May 2002
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The purposes of this study are:

  1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
  2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy individual
  • age:18-49 years
  • able to read and understand English
  • able to attend al study visits
  • access to a telephone (to schedule visits)

Exclusion Criteria:

  • current smoking
  • asthma
  • current use of any prescription or psychoactive medications or supplements
  • either:

    1. no prior experience with RR eliciting techniques
    2. at least 3 years of regular RR elicitation (at least 20 min/day)
  • BMI >30
  • exhaled nitric oxide levels >60 ppb
  • abnormal lab values (Hct <32,creatinine >1.3, glucose >200
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179595


Locations
United States, Massachusetts
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Herbert Benson, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179595     History of Changes
Other Study ID Numbers: 2001P001747
H75-CCH-123424
H75-CCH-119124
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Beth Israel Deaconess Medical Center:
nitric oxide, volumetric oxygen consumption