- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01816360
Aromatherapy and Yogatherapy for Hot Flashes
March 19, 2013 updated by: Cassandra Santantonio de Lyra, MSc, University of Sao Paulo
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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São Paulo, Brazil
- Universidade de São Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aromatherapy group
20 sessions of olfactory aromatherapy using protocol.
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Inhalation of essential oils.
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EXPERIMENTAL: Yogatherapy group
20 sessions of yogatherapy with aroma-placebo using protocol.
|
Yogatherapy respiratory exercises.
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EXPERIMENTAL: Aromatherapy-Yogatherapy group
20 sessions of yogatherapy with olfactory aromatherapy, using protocol.
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Inhalation of essential oils.
Yogatherapy respiratory exercises.
|
NO_INTERVENTION: Control group
Control group in the waiting-list model (all volunteers were offered the treatment after the completion of data collection).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequence and intensity of hot flashes
Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Change in frequence and intensity of hot flashes using questionnaire developed for this study.
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Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of sleep
Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.
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Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Body resonance
Time Frame: Before intervention
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Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.
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Before intervention
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Psycho-social influences on the effects of the aroma.
Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Influence of aroma preferences and olfactory memories in effects of aroma.
Changes in aroma preferences.
Using questionnaire developed for this study.
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Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Personal data
Time Frame: Before intervention
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Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.
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Before intervention
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Change in stress level
Time Frame: At beginning of study and after each session of intervention (twice a week for 10 weeks).
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Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.
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At beginning of study and after each session of intervention (twice a week for 10 weeks).
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Change in quality of life
Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
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Change in quality of life measured by the SF-36 questionnaire.
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Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cassandra S Lyra, MSc, Doctoral student at Universidade de Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
March 18, 2013
First Submitted That Met QC Criteria
March 19, 2013
First Posted (ESTIMATE)
March 22, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 22, 2013
Last Update Submitted That Met QC Criteria
March 19, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AromaYoga
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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