Acupuncture as a Complementary Treatment for Hypertension (ACT-HAS)

Hypertensive Disease Clinical Trial

— ACT-HAS  

Official title:

Acupuncture as Applied Technology to Nursing Care Adult Hypertensive: An Experimental Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530853
• Other study ID #: 32909414.4.1001.5238
• Secondary ID: 772.508
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: August 21, 2015
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: Universidade Federal do Rio de Janeiro
• Contact: Raphael Pereira
• Phone: 5521984531421
• Email: rdias_46[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This is a randomized clinical trial with blinded, multi-center, involving the Federal University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of in Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by building doctorate thesis as a final product of the research.

Description:

The objective of investigation is the effectiveness of acupuncture as a complementary health care to patients with primary hypertension drug therapy.

Methodological approach - Randomized Clinical Trial triple blind.

Population / sample - Patients with Primary Hypertension in drug treatment for over a year and no effective control of blood pressure levels, that is, regular saving measures above was over 140x90 mmHg.

How centers Participants Research, the study covers health units of the Municipal Health of Maricá in Rio de Janeiro, the Municipal of Victoria Health in Espirito Santo, beyond the scope of Integrated Project Research-Service (PIPA), linked to School Nursing Anna Nery /UFRJ.

Primary Objective - To evaluate the effectiveness of acupuncture as a complementary health practice associated with drug treatment used in adults with primary hypertension, based on nursing diagnoses.

Secondary objectives:

• Estimate blood pressure levels after exposure to acupuncture applied in adults with primary hypertension.

• Draw the profile of the most frequent nursing diagnoses in adults with primary hypertension.

• Analyze the effectiveness of acupuncture as a complementary health therapy associated with drug treatment used on these clients, based on nursing diagnoses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Be suffering from essential hypertension;

• Be properly prescribed medication and have difficulty controlling blood pressure keeping regular measurement above was over 140x90 mmHg.

Exclusion Criteria:

• A woman in pregnancy;

• Be in possession of any type of cancer;

• being a smoker;

• be alcoholic;

• Be in drug treatment for other diseases including obesity;

• Not dieting for weight loss;

• practice regular physical activity.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disease

Intervention

Other:
• Laser acupuncture
Laser acupuncture

Locations

Country	Name	City	State
Brazil	Raphael	Rio de Janeiro	Maricá

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of blood pressure levels.		six weeks	No
Secondary	Improvement of nursing diagnoses		six weeks	No