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

Phase 4

• Conditions: Climacteric
• Interventions: Other: flower therapy; Other: therapeutic touch; Other: auricular therapy; Drug: Hormones

• Registration Number: NCT00617500
• Lead Sponsor: Sociedade Hospital Samaritano

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Study Start: 2008-07
• Primary Completion: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-22
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 278

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flower therapy	flower therapy	-
therapeutic touch	therapeutic touch	-
auriculotherapy	auricular therapy	-
Hormone	Hormones	-

Primary Outcome Measures

Name	Time	Method
annoying signs and climacteric symptoms	pre and post intervention

Trial Locations

Locations (2)

Hospital Samaritano; 🇧🇷 São Paulo, Brazil

Nursing School of University of São Paulo; 🇧🇷 São Paulo, Brazil