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

NCT ID: NCT02530853

Last Updated: 2015-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertensive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Laser acupuncture

Group Type EXPERIMENTAL

Laser acupuncture

Intervention Type OTHER

Laser acupuncture

Group B

Simulation Laser acupuncture

Group Type SHAM_COMPARATOR

Laser acupuncture

Intervention Type OTHER

Laser acupuncture

Interventions

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Laser acupuncture

Laser acupuncture

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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NEIDE APARECIDA TITONELLI ALVIM

PhD, Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neide Alvim

Role: STUDY_DIRECTOR

UFRJ

Claudia Pereira

Role: STUDY_CHAIR

UFRJ

Locations

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Raphael

Rio de Janeiro, Maricá, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Raphael Pereira

Role: CONTACT

5521984531421

UFRJ PIPA

Role: CONTACT

552122913098

Facility Contacts

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Raphael Pereira

Role: primary

References

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Pereira RDM, Alvim NAT, Pereira CD, Gomes Junior SCDS. Laser acupuncture protocol for essential systemic arterial hypertension: randomized clinical trial. Rev Lat Am Enfermagem. 2018 Jul 16;26:e2936. doi: 10.1590/1518-8345.1887.2936.

Reference Type DERIVED
PMID: 30020330 (View on PubMed)

Other Identifiers

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772.508

Identifier Type: OTHER

Identifier Source: secondary_id

32909414.4.1001.5238

Identifier Type: -

Identifier Source: org_study_id

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