Aromatherapy and Yogatherapy for Hot Flashes

NCT ID: NCT01816360

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to verify and analyse psychological and physiological effects of olfactory aromatherapy and yogatherapy respiratory exercises, together and separately, on the quality of life, levels of stress, quality of sleep and intensity and frequence of hot flashes in climacteric women.

Detailed Description

Introduction: Menopause is the period in which reproductive life ends and senescence begins. Because of the increase in life expectancy there are more women reaching this period. Although it is a physiological change, it is frequently accompanied by disagreeable symptoms that can influence quality of life and sleep in a negative manner. The most common symptom is hot flashes. The traditional treatment for the symptoms is hormone replacement therapy, that has many important side effects, such as increase in cancer incidence. This therapy also has dubious effects on psychosexual symptoms and quality of life. This justifies the study of other more secure treatments. Aromatherapy can be a particularly efficacious treatment for hot flashes because it has therapeutic mechanisms that are similar to the physiological mechanisms of hot flashes. It is also a secure therapy with little side effects, specially when applied in inhalation (olfactory aromatherapy). Yogatherapy can also influence psychoneuroedocrineimmunological axis similar to the physiological axis of hot flashes. Yogatherapy includes respiratory exercises that can potentiate the effects of olfactory aromatherapy. Because of this, it can be beneficial to apply aromatherapy and yogatherapy together. These therapies were studied as they are applied in clinical practice. The psychoneuroendocrineimmunological model permits the study of the effects of both these therapies aiming at increase in quality of life, from a psychosomatic and global point of view. The global approach is important in the study of menopause because it has both psychological and physiological characteristics. Objective: verify and analyse psychological and physiological effects of olfactory aromatherapy and yogatherapy respiratory exercises, together and separately, on the quality of life, levels of stress, quality of sleep and intensity and frequence of hot flashes in climacteric women. Material and methods: The study is a placebo-controlled double-blind clinical trial, with restrict randomization methods (that allow groups of the same size). Recruitment of voluntaries was made using posters and electronic messages in websites. Data was collected at the "Centro de Práticas Esportivas da Universidade de São Paulo" (Sport Centre of the University of Sao Paulo). The study will have four groups: aromatherapy, yogatherapy, both therapies and control-placebo group. Appraisal was done using questionnaires for personal data, social-economical data, stress levels, quality f sleep levels, body resonance levels, quality of life levels, climacteric influence on quality of life and physiological data (heart rate, breathing rate, blood pressure and body temperature). Appraisal was done before, during and after 20 treatment sessions. The research was approved by the "Comitê de Ética em Pesquisa da Escola de Educação Fisica e Esporte da Universidade de São Paulo" (Ethics Committee of the Sport and Physical Education School of the University of Sao Paulo). Data will be analysed using descriptive statistics, Student t-test, ANOVA variance analysis and Pearson correlation, considering significance levels of p<0,05.

Conditions

Menopause; Hot Flashes; Hot Flushes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Aromatherapy group

20 sessions of olfactory aromatherapy using protocol.

Group Type: EXPERIMENTAL

Olfactory aromatherapy

Intervention Type: OTHER

Inhalation of essential oils.

Yogatherapy group

20 sessions of yogatherapy with aroma-placebo using protocol.

Group Type: EXPERIMENTAL

Yogatherapy

Intervention Type: OTHER

Yogatherapy respiratory exercises.

Aromatherapy-Yogatherapy group

20 sessions of yogatherapy with olfactory aromatherapy, using protocol.

Group Type: EXPERIMENTAL

Olfactory aromatherapy

Intervention Type: OTHER

Inhalation of essential oils.

Yogatherapy

Intervention Type: OTHER

Yogatherapy respiratory exercises.

Control group

Control group in the waiting-list model (all volunteers were offered the treatment after the completion of data collection).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Olfactory aromatherapy

Inhalation of essential oils.

Intervention Type: OTHER

Yogatherapy

Yogatherapy respiratory exercises.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age from 45 to 60 years
• Women who reported having hot flashes for at least 6 months

Exclusion Criteria

• History of hysterectomy, oophorectomy or endometrial ablation
• Chemotherapy in the last 5 years
• Women receiving treatment for menopausal symptoms (including hormone replacement therapy)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cassandra Santantonio de Lyra, MSc

Master in Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cassandra S Lyra, MSc

Role: PRINCIPAL_INVESTIGATOR

Doctoral student at Universidade de Sao Paulo

Locations

Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

AromaYoga

Identifier Type: -

Identifier Source: org_study_id