NCT00617500

Brief Summary

The alternative and complementary therapies are being gradually included in the Brazilian Health Unique System (SUS), as it is foreseen in the National Politics of Integrative and Complementary Practices in Brazil . However, though this thematic is also included in the National Agenda of Research Priorities concerning Health, published studies concerning this matter are quite scarce. The World Health Organization (WHO) indicated that it is a big challenge to effect the following studies: cost-effectiveness, as well as safety, efficiency and the quality of such practices. WHO also pointed out the clinical situations where they could be applied and that is why this investigation we are undertaken is fully justified. Annoying signs and symptoms which come along with the climacteric period, especially anxiety, insomnia and hot flushes, change women´s life quality and their affective, social and business relationships as well. Consequently, this can generate sadness, depression and isolation. Many women cannot undergo hormonal replacement, for several reasons: or they have some illnesses which reject hormones, or due to hypersensitiveness reactions or even economical difficulties. Also, the cost-effectiveness ratio between conventional therapy of hormonal replacement and complementary therapies which compose this study are not known yet . The complementary therapies proposed in this study concern non-invasive methods, of low cost, which justify being researched in order to verify the potential of those annoying signs alleviation.

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
278

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 23, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

January 23, 2008

Last Update Submit

September 18, 2009

Conditions

Climacteric

Keywords

climactericcomplementary therapyhormonal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • annoying signs and climacteric symptoms

    pre and post intervention

Study Arms (4)

Hormone

ACTIVE COMPARATOR
Drug: Hormones

flower therapy

EXPERIMENTAL
Other: flower therapy

therapeutic touch

EXPERIMENTAL
Other: therapeutic touch

auriculotherapy

EXPERIMENTAL
Other: auricular therapy

Interventions

flower therapyOTHER

Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

flower therapy
therapeutic touchOTHER

Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

therapeutic touch
auricular therapyOTHER

Each woman will perform 12 sessions of 20 to 30 minutes, depending on the treatment group, with weekly intervals performed in one of the consultation rooms.

auriculotherapy
HormonesDRUG

Estradiol 1 mg and a drospirenone 2mg/day (3 months)

Hormone

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Recruited and registered in local of the study
  • They should present the signs and symptoms checked - insomnia, anxiety and hot flushes, they felt at the beginning of the climacteric
  • They should not be under hormonal replacement or even should have stopped their use more than 90 days

You may not qualify if:

  • women who undergo a hysterectomy surgery
  • women using hormonal therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Samaritano

São Paulo, São Paulo, 01232-010, Brazil

Location

Nursing School of University of São Paulo

São Paulo, São Paulo, 01232-010, Brazil

Location

MeSH Terms

Interventions

Therapeutic TouchHormones

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Eliseth R Leão, PhD

    Hospital Samaritano

    STUDY DIRECTOR

  • Maria Julia P Silva, PhD

    University of Sao Paulo

    STUDY DIRECTOR

  • Léia Sales, MscN

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Ivaldo da Silva, PhD

    Tocogynecological Department of São Paulo Federal University

    PRINCIPAL INVESTIGATOR

  • Maria C Martinez, PhD

    Hospital Samaritano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 18, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

November 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

BR(2)