Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04854265 |
| Other study ID # |
U/SERC/171 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2021 |
| Est. completion date |
December 24, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Universiti Tunku Abdul Rahman |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Hypertension (HTN) is a common cardiovascular disorder present globally. In spite of various
treatment approaches utilized in treating HTN, there is a surge in popularity of mindfulness
meditation (MM) in recent years. Although multiple techniques of MM are advocated to be
efficient in the treatment of HTN among hypertensive adults, the level of supportive evidence
is variable and limited. Therefore authors aim to conduct a systematic review to investigate
the effectiveness of mindfulness meditation on blood pressure (BP) among young adults.
Description:
Hypertension (HTN) is one of the major culprit of cardiovascular disease and is potentially
leading to premature death and disability globally, exerting tremendous burden to public
health. A study in 2019 reported that globally, HTN affects 26% of world's population (972
million people), and the prevalence is expected to increase to approximately 29% by 2025,
which is driven largely by increase in economically developing nations. World Health
Organization (WHO) in year 2015 stated that there is 1 in every 4 men and 1 in every 5 women
who had hypertension. A high prevalence of HTN highly cognate with diverse risk factors such
as age, gender, ethnicity as well as other modifiable factors like unhealthy diet and
physical inactivity.
Treatment of hypertension ranges from pharmacological approach to lifestyle changes.
Antihypertensive medicines like Beta blockers, Calcium channel blocker, Alpha blockers,
diuretics and angiotensin receptor blocker are casually used in controlling and lowering the
blood pressure (BP). The cost of these ,medications is huge and are accompanied by many side
effects. Due to this, HTN centered lifestyle modifications has now become a cornerstone as
primary non-pharmacological first line therapy in the treatment of hypertension. Lifestyle
modifications on HTN emphasize on smoking cessation, a healthy diet with more fruits and
vegetables consumption, regular exercise of 10-20 minutes daily and so on. One of the
lifestyle modification found to be effective and potentially able to reduce the high BP as
potent as an antihypertensive drug is mindfulness meditation (MM). It is reported to reduce
the diastolic BP by 2 mmHg which can significantly reduce the pervasiveness of HTN of about
17%, risk of befalling stroke by 15% and coronary heart disease by 6%.
There is no extensive peer-reviewed studies available to fortify the evidence of MM on HTN,
as BP is affected by a combination of genetic, behavioral and environmental factors which
cannot be easily controlled by meditation alone. In addition to that, to our knowledge no
systematic reviews have been published on topic of MT effect on BP among hypertensive adults.
Due to this, it is indispensable this study to be conducted to investigate the effect of MT
in controlling BP among hypertensive adults.
This systematic review will adherence to Cochrane guidelines. We will conduct an extensive
search of electronic databases such as the National Library of Medicine, Hindawi, Cochrane
library, Cochrane library Central Register of Control Trial, MEDLINE, Pub Med and PEDro for
eligible studies between 2000 to 2020. We will ensure that at least two bibliographic
databases are involved for systematic review to avoid publication bias and promote
generalizability of the results. To Attain optimal sensitivity and identify, all possible
trials of MM on HTN, cluster of search terms will be created for the types of intervention
(mindfulness or mindfulness meditations or Yoga or Tai Chi or QiGong) and another for
population (Hypertension or high blood pressure). The clusters will be combined with AND and
OR terms within the cluster.
In this systematic review, criteria for inclusion will be studies which are of randomized
control trial design irrespective of type of MM used, any relevant studies published between
year 2000 and 2020. In the aspect of sample population, adults whose age is between 18-60
years or mean age below 60 years will be selected. According to America Heart Association,
only adults with stage 1 HTN (130-139/80-89 mmHg), stage 2 HTN (>140/90 mmHg) or HTN crisis
(>180/120) will be chosen in this review regardless of the severity or type of HTN (primary
or secondary). In addition, hypertensive patients with any other underlying health conditions
(heart disease, chronic kidney disease) will be included in this study. Exclusion criteria
will be studies published before 2000, studies which are not reported in English, studies
which did not report BP as outcome measure, as well as BP measurement not implemented in a
pre-test and post-test basis, studies which only report as abstract.
Qualitative analysis of the included studies will be used to establish narrative synthesis.
Besides, we will also incorporate tabulation with narrative synthesis to allow comparison of
findings to be made more easily. Post intervention differences in SBP and DBP between control
and experimental group will be scrutinized descriptively by using measures of treatment
effect.
