Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01816360
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2013-03-18
Brief Title:
Aromatherapy and Yogatherapy for Hot Flashes
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None