Condition category
Circulatory System
Date applied
21/09/2005
Date assigned
18/01/2006
Last edited
09/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes