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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
September 13, 2005
September 16, 2005
February 16, 2017
May 2002
October 2011   (Final data collection date for primary outcome measure)
To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
Same as current
Complete list of historical versions of study NCT00179595 on ClinicalTrials.gov Archive Site
To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.
Same as current
Not Provided
Not Provided
 
Does the Relaxation Response Inhibit Acute Stress?
Does the Relaxation Response Inhibit Acute Stress?

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Health Services Research
Healthy
Behavioral: relaxation response- meditation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00179595
2001P001747
H75-CCH-123424
H75-CCH-119124
No
Not Provided
Plan to Share IPD: No
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Centers for Disease Control and Prevention
Principal Investigator: Herbert Benson, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP