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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530853
Recruitment Status : Unknown
Verified August 2015 by NEIDE APARECIDA TITONELLI ALVIM, Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : August 21, 2015
Last Update Posted : August 25, 2015
Sponsor:
Collaborators:
Ministry of Health, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
NEIDE APARECIDA TITONELLI ALVIM, Universidade Federal do Rio de Janeiro

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertensive Disease Other: Laser acupuncture Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture as Applied Technology to Nursing Care Adult Hypertensive: An Experimental Study.
Study Start Date : August 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Group A
Laser acupuncture
Other: Laser acupuncture
Laser acupuncture

Sham Comparator: Group B
Simulation Laser acupuncture
Other: Laser acupuncture
Laser acupuncture




Primary Outcome Measures :
  1. Improvement of blood pressure levels. [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. Improvement of nursing diagnoses [ Time Frame: six weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530853


Contacts
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Contact: Raphael Pereira 5521984531421 rdias_46@hotmail.com
Contact: UFRJ PIPA 552122913098 pesquisacupunt@ufrj.br

Locations
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Brazil
Raphael Recruiting
Rio de Janeiro, Maricá, Brazil
Contact: Raphael Pereira       pesquisacupunt@ufrj.br   
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Ministry of Health, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Study Director: Neide Alvim UFRJ
Study Chair: Claudia Pereira UFRJ
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NEIDE APARECIDA TITONELLI ALVIM, PhD, Nurse, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02530853    
Other Study ID Numbers: 32909414.4.1001.5238
772.508 ( Other Identifier: Nº do Parecer do CEP )
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases