Contact information
Type
Scientific
Primary contact
Prof Wolfram Voelker
ORCID ID
Contact details
Joseph-Schneider-Strasse 2
Wuerzburg
97070
Germany
+49 931 201 36328
voelker_w@klinik.uni-wuerzburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Meditation Study
Study hypothesis
Meditation in the Christian tradition combined with breathing techniques reduces ambulatory and stress-induced blood pressure in essential hypertension
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Essential untreated hypertension
Intervention
Randomisation 1:1 into meditation versus no meditation. The intervention consists of a four-week introductory course and a four-week intensive training phase. During these eight weeks, meditation in the Christian tradition and breathing techniques are taught by a certified meditation facilitator. Meditation sessions (40 minutes) are held daily as group meetings in the early evening. In addition, meditation is practiced daily individually at home in the morning. At baseline and after eight weeks, all participants undergo the following tests:
1. Standardised computerised mental stress test
2. Bicycle ergometry
3. 24 hour ambulatory blood pressure (BP) measurement
4. 24 hour Holter electrocardiogram (ECG)
5. Echocardiography
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Median change in systolic BP during mental stress in the intervention group compared with controls.
Secondary outcome measures
1. Median change in systolic and diastolic resting BP, during 24 hour ambulatory BP monitoring, exercise test (intervention group versus controls, respectively)
2. Difference in heart rate variability (Holter)
3. Diastolic function in echocardiography
Overall trial start date
01/03/2004
Overall trial end date
30/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 30 and 65 years
2. Written informed consent
3. Elevated resting blood pressure (more than 140/85 mmHg) on three occasions within four weeks
4. Primary hypertension confirmed by laboratory testing, clinical history and examination, abdominal ultrasound
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
52
Participant exclusion criteria
1. Previous training in contemplative meditation
2. Secondary hypertension
3. Blood pressure more than 180/110 mmHg
4. Antihypertensive therapy within the last 12 months
5. Pregnancy
6. Alcohol abuse
7. Immunosuppressive medication
8. Diabetes
Recruitment start date
01/03/2004
Recruitment end date
30/06/2004
Locations
Countries of recruitment
Germany
Trial participating centre
Joseph-Schneider-Strasse 2
Wuerzburg
97070
Germany
Sponsor information
Organisation
University of Wuerzburg (Germany)
Sponsor details
Sanderring 2
Wuerzburg
97070
Germany
+49 931 31 2231
kanzler@zv.uni-wuerzburg.de
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17823597
Publication citations
-
Results
Manikonda JP, Störk S, Tögel S, Lobmüller A, Grünberg I, Bedel S, Schardt F, Angermann CE, Jahns R, Voelker W, Contemplative meditation reduces ambulatory blood pressure and stress-induced hypertension: a randomized pilot trial., J Hum Hypertens, 2008, 22, 2, 138-140, doi: 10.1038/sj.jhh.1002275.