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

Primary Purpose

Hypertensive Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser acupuncture
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RaphaelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group A

Group B

Arm Description

Laser acupuncture

Simulation Laser acupuncture

Outcomes

Primary Outcome Measures

Improvement of blood pressure levels.

Secondary Outcome Measures

Improvement of nursing diagnoses

Full Information

First Posted
August 19, 2015
Last Updated
August 21, 2015
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Ministry of Health, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02530853
Brief Title
Acupuncture as a Complementary Treatment for Hypertension (ACT-HAS)
Acronym
ACT-HAS
Official Title
Acupuncture as Applied Technology to Nursing Care Adult Hypertensive: An Experimental Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Ministry of Health, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Laser acupuncture
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
Simulation Laser acupuncture
Intervention Type
Other
Intervention Name(s)
Laser acupuncture
Intervention Description
Laser acupuncture
Primary Outcome Measure Information:
Title
Improvement of blood pressure levels.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Improvement of nursing diagnoses
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael Pereira
Phone
5521984531421
Email
rdias_46@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
UFRJ PIPA
Phone
552122913098
Email
pesquisacupunt@ufrj.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neide Alvim
Organizational Affiliation
UFRJ
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claudia Pereira
Organizational Affiliation
UFRJ
Official's Role
Study Chair
Facility Information:
Facility Name
Raphael
City
Rio de Janeiro
State/Province
Maricá
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael Pereira
Email
pesquisacupunt@ufrj.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
30020330
Citation
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.
Results Reference
derived

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

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