Clinical trial NCT01816360: Aromatherapy and Yogatherapy for Hot Flashes
Official title: The Effects of Olfactory Aromatherapy and Yogatherapy Breathing Exercises on the Quality of Life, Stress Levels, Coping Strategies and Hot Flashes Intensity and Frequence in Climacteric Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Hot Flashes
Hot Flushes
Keywords: Womens health
Menopause
Complementary therapies
Aromatherapy
Essential oils
Yogatherapy
Psychoneuroendocrineimmunology
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 108
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change in frequence and intensity of hot flashes
timeFrame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Secondary outcomes:
measure: Change in quality of sleep
timeFrame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
measure: Body resonance
timeFrame: Before intervention
measure: Psycho-social influences on the effects of the aroma.
timeFrame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
measure: Personal data
timeFrame: Before intervention
measure: Change in stress level
timeFrame: At beginning of study and after each session of intervention (twice a week for 10 weeks).
measure: Change in quality of life
timeFrame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
Study officials:
affiliation: Doctoral student at Universidade de Sao Paulo
name: Cassandra S Lyra, MSc
role: PRINCIPAL_INVESTIGATOR
References: