Effect of meditation combined with breathing technique on mental and exercise-induced hypertension
| ISRCTN | ISRCTN21417206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21417206 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/09/2005
- Registration date
- 18/01/2006
- Last edited
- 09/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Wolfram Voelker
Scientific
Scientific
Joseph-Schneider-Strasse 2
Wuerzburg
97070
Germany
| Phone | +49 931 201 36328 |
|---|---|
| voelker_w@klinik.uni-wuerzburg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | Meditation Study |
| Study objectives | Meditation in the Christian tradition combined with breathing techniques reduces ambulatory and stress-induced blood pressure in essential hypertension |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2004 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 52 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Joseph-Schneider-Strasse 2
Wuerzburg
97070
Germany
97070
Germany
Sponsor information
University of Wuerzburg (Germany)
University/education
University/education
Sanderring 2
Wuerzburg
97070
Germany
| Phone | +49 931 31 2231 |
|---|---|
| kanzler@zv.uni-wuerzburg.de | |
"ROR" |
https://ror.org/00fbnyb24 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | Yes | No |
