Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Climacteric Clinical Trial : the Use of Complementary Therapy and Hormonal Replacement

Conditions
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Climacteric

Intervention / Treatment
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* Other: flower therapy
* Other: therapeutic touch
* Other: auricular therapy
* Drug: Hormones


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hormone<br> | Drug: Hormones<br>* Estradiol 1 mg and a drospirenone 2mg/day (3 months)<br>|
| Experimental: flower therapy<br> | Other: flower therapy<br>* 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.<br>|
| Experimental: therapeutic touch<br> | Other: therapeutic touch<br>* 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.<br>|
| Experimental: auriculotherapy<br> | Other: auricular therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annoying signs and climacteric symptoms |  | pre and post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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climacteric, complementary therapy, hormonal replacement therapy