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Sponsors and Collaborators: |
Sociedade Hospital Samaritano University of Sao Paulo |
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Information provided by: | Sociedade Hospital Samaritano |
ClinicalTrials.gov Identifier: | NCT00617500 |
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.
Condition | Intervention |
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Climacteric |
Other: flower therapy Other: therapeutic touch Other: auricular therapy Drug: Hormones |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement |
Estimated Enrollment: | 278 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Hormone: Active Comparator |
Drug: Hormones
Estradiol 1 mg and a drospirenone 2mg/day (3 months)
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flower therapy: Experimental |
Other: 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.
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therapeutic touch: Experimental |
Other: 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.
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auriculotherapy: Experimental |
Other: 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.
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Ages Eligible for Study: | 45 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contact: Eliseth R Leão, PhD | 55 11 38215891 | eliseth.leao@samaritano.org.br |
Brazil | |
Hospital Samaritano | Recruiting |
São Paulo, Brazil, 01232-010 | |
Contact: Eliseth R Leão, PhD 55 11 38215891 eliseth.leao@samaritano.org.br | |
Principal Investigator: Eliseth R Leão, PhD | |
Sub-Investigator: Maria Julia P Silva, PhD | |
Nursing School of University of São Paulo | Recruiting |
São Paulo, Brazil, 01232-010 | |
Contact: Maria Julia P Silva, PhD 55 11 30617544 juliaps@usp.br | |
Principal Investigator: Eliseth R Leão, PhD | |
Sub-Investigator: Maria Julia P Silva, PhD |
Study Director: | Eliseth R Leão, PhD | Hospital Samaritano |
Study Director: | Maria Julia P Silva, PhD | University of São Paulo |
Principal Investigator: | Léia Sales, MscN | University of São Paulo |
Principal Investigator: | Ivaldo da Silva, PhD | Tocogynecological Department of São Paulo Federal University |
Principal Investigator: | Maria C Martinez, PhD | Hospital Samaritano |
Responsible Party: | Scientific Research Department of Samaritano Hospital ( Eliseth Ribeiro Leão ) |
Study ID Numbers: | SHS 18/07 |
Study First Received: | January 23, 2008 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00617500 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
climacteric complementary therapy hormonal replacement therapy |
Estradiol 3-benzoate Estradiol valerate Drospirenone Estradiol 17 beta-cypionate |
Polyestradiol phosphate Hormones Estradiol |