Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401278
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure In Primary Hypertension Patients
Sponsor:
Tawfik Tawfik Mahmoud Emara
Organization:
Cairo University
Study Overview
Official Title:
Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure And Quality Of Life In Patients With Primary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
BACKGROUND
The current American College of Cardiology and the American Heart Association ACCAHA 2017 guidelines define hypertension as systolic BP SBP of 130 mmHg or diastolic BP DBP of 80 mmHg In adults an increase of 20 mmHg in SBP or 10 mmHg in DBP is associated with more than a two-fold increase in mortality owing to stroke and other cardiovascular diseases Hypertension accounts for 13 of premature deaths worldwide and is the third leading cause of disability-adjusted life years Shah et al 2022
Transcutaneous electrical nerve stimulation of the Neiguan P6 point with acupressure is possibly affecting the blood pressure by protecting the myocardial tissues and influencing the nervous system through regulating the autonomic nervous system function and reduction in sympathetic activity Hassanein et al 2021
HYPOTHESES There will be no a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
RESEARCH QUESTION
Is there a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
Evaluating equipment pre-post intervension outcomes
1 BP by Digital Sphygmomanometer
2 quality of life by The SF-12 health status questionnaire
3 nitric oxide level in blood by nitric Oxide analysis
4 sleep quality by Pittsburgh Sleep Quality Index PSQI
5 exercise capacity and endurance by Thirty-Second Sit-To-Stand Test 30 STST
BACKGROUND
The current American College of Cardiology and the American Heart Association ACCAHA 2017 guidelines define hypertension as systolic BP SBP of 130 mmHg or diastolic BP DBP of 80 mmHg In adults an increase of 20 mmHg in SBP or 10 mmHg in DBP is associated with more than a two-fold increase in mortality owing to stroke and other cardiovascular diseases Hypertension accounts for 13 of premature deaths worldwide and is the third leading cause of disability-adjusted life years Shah et al 2022
Transcutaneous electrical nerve stimulation of the Neiguan P6 point with acupressure is possibly affecting the blood pressure by protecting the myocardial tissues and influencing the nervous system through regulating the autonomic nervous system function and reduction in sympathetic activity Hassanein et al 2021
HYPOTHESES There will be no a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
RESEARCH QUESTION
Is there a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
Evaluating equipment pre-post intervension outcomes
1 BP by Digital Sphygmomanometer
2 quality of life by The SF-12 health status questionnaire
3 nitric oxide level in blood by nitric Oxide analysis
4 sleep quality by Pittsburgh Sleep Quality Index PSQI
5 exercise capacity and endurance by Thirty-Second Sit-To-Stand Test 30 STST
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None