Overview

This trial is active, not recruiting.

Condition climacteric
Treatments flower therapy, therapeutic touch, auricular therapy, hormones
Phase phase 4
Sponsor Sociedade Hospital Samaritano
Collaborator University of Sao Paulo
Start date July 2008
End date December 2008
Trial size 278 participants
Trial identifier NCT00617500, SHS 18/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
hormones
Estradiol 1 mg and a drospirenone 2mg/day (3 months)
(Experimental)
flower therapy
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.
(Experimental)
therapeutic touch
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.
(Experimental)
auricular therapy
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.

Primary Outcomes

Measure
annoying signs and climacteric symptoms
time frame: pre and post intervention

Eligibility Criteria

Female participants from 45 years up to 55 years old.

Inclusion Criteria: - 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 Exclusion criteria: - women who undergo a hysterectomy surgery - women using hormonal therapy

Additional Information

Official title Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement
Principal investigator Léia Sales, MscN
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Sociedade Hospital Samaritano.