NCT02530853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

August 19, 2015

Last Update Submit

August 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement of blood pressure levels.

    six weeks

Secondary Outcomes (1)

  • Improvement of nursing diagnoses

    six weeks

Study Arms (2)

Group A

EXPERIMENTAL

Laser acupuncture

Other: Laser acupuncture

Group B

SHAM COMPARATOR

Simulation Laser acupuncture

Other: Laser acupuncture

Interventions

Laser acupuncture

Group AGroup B

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raphael

Rio de Janeiro, Maricá, Brazil

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Neide Alvim

    UFRJ

    STUDY DIRECTOR
  • Claudia Pereira

    UFRJ

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Nurse

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 21, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations