Acupuncture as a Complementary Treatment for Hypertension... | NCT02530853

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

NCT02530853

Sponsor

Universidade Federal do Rio de Janeiro

Status

Unknown status

Last Update Posted

Aug 25, 2015Estimated

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Hypertensive Disease

Interventions

Laser acupuncture

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
772.508	Other Identifier	Nº do Parecer do CEP

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Aug 19, 2015

First Submission Date that Met QC Criteria

Aug 20, 2015

First Posted Date

Aug 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2015

Last Update Posted Date

Aug 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

NEIDE APARECIDA TITONELLI ALVIM, PhD, Nurse, Universidade Federal do Rio de JaneiroPrincipal Investigator

Lead Sponsor

Universidade Federal do Rio de JaneiroOTHER

Collaborators

Name	Class
Ministry of Health, Brazil	OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Laser acupuncture	Other: Laser acupuncture
Group B	Sham Comparator	Simulation Laser acupuncture	Other: Laser acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser acupuncture	Other	Laser acupuncture	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of blood pressure levels.		six weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement of nursing diagnoses		six weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Raphael Pereira	Contact	5521984531421		rdias_46@hotmail.com
UFRJ PIPA	Contact	552122913098		pesquisacupunt@ufrj.br

Overall Officials

Name	Affiliation	Role
Neide Alvim	UFRJ	Study Director
Claudia Pereira	UFRJ	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Raphael	Recruiting	Rio de Janeiro	Maricá		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30020330	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases