MenopauseNCT01816360
Aromatherapy and Yogatherapy for Hot Flashes
A study testing Olfactory aromatherapy and Yogatherapy in people with Menopause and Hot Flashes, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes, Hot Flushes
- What is being tested?
- Olfactory aromatherapy and Yogatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 45 to 60 years
- Women who reported having hot flashes for at least 6 months
Who cannot join
- History of hysterectomy, oophorectomy or endometrial ablation
- Chemotherapy in the last 5 years
- Women receiving treatment for menopausal symptoms (including hormone replacement therapy)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Olfactory aromatherapy, Yogatherapy
- Keywords
- Womens health, Menopause, Complementary therapies, Aromatherapy, Essential oils, Yogatherapy, Psychoneuroendocrineimmunology
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory aromatherapyOther
Inhalation of essential oils.
YogatherapyOther
Yogatherapy respiratory exercises.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy group | Experimental | 20 sessions of olfactory aromatherapy using protocol. Receives: Other: Olfactory aromatherapy |
| Yogatherapy group | Experimental | 20 sessions of yogatherapy with aroma-placebo using protocol. Receives: Other: Yogatherapy |
| Aromatherapy-Yogatherapy group | Experimental | 20 sessions of yogatherapy with olfactory aromatherapy, using protocol. Receives: Other: Olfactory aromatherapy; Other: Yogatherapy |
| Control group | No intervention | Control group in the waiting-list model (all volunteers were offered the treatment after the completion of data collection). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequence and intensity of hot flashes
Change in frequence and intensity of hot flashes using questionnaire developed for this study.
Measured: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Secondary outcomes (6)
Change in quality of sleep
Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.
Measured: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Body resonance
Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.
Measured: Before intervention
Psycho-social influences on the effects of the aroma.
Influence of aroma preferences and olfactory memories in effects of aroma. Changes in aroma preferences. Using questionnaire developed for this study.
Measured: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Personal data
Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.
Measured: Before intervention
Change in stress level
Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.
Measured: At beginning of study and after each session of intervention (twice a week for 10 weeks).
Change in quality of life
Change in quality of life measured by the SF-36 questionnaire.
Measured: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassandra Santantonio de Lyra, MSc, University of Sao Paulo
- Investigators
- Cassandra S Lyra, MSc, Principal investigator, Doctoral student at Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816360
- Sponsor's protocol ID
- AromaYoga
- Status last verified
- Mar 2013
- First submitted
- 18 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01816360
- Acronym / sponsor ID
- AromaYoga
- Conditions
- Menopause, Hot Flashes, Hot Flushes
- Keywords
- Womens health, Menopause, Complementary therapies, Aromatherapy, Essential oils, Yogatherapy, Psychoneuroendocrineimmunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy group | Experimental | Other: Olfactory aromatherapy20 sessions of olfactory aromatherapy using protocol. |
| Yogatherapy group | Experimental | Other: Yogatherapy20 sessions of yogatherapy with aroma-placebo using protocol. |
| Aromatherapy-Yogatherapy group | Experimental | Other: Olfactory aromatherapy, Other: Yogatherapy20 sessions of yogatherapy with olfactory aromatherapy, using protocol. |
| Control group | No intervention | –Control group in the waiting-list model (all volunteers were offered the treatment after the completion of data collection). |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age from 45 to 60 years
- Women who reported having hot flashes for at least 6 months
Key exclusion criteria (3 listed)
- History of hysterectomy, oophorectomy or endometrial ablation
- Chemotherapy in the last 5 years
- Women receiving treatment for menopausal symptoms (including hormone replacement therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory aromatherapyInhalation of essential oils. | Other | Aromatherapy group, Aromatherapy-Yogatherapy group |
| YogatherapyYogatherapy respiratory exercises. | Other | Aromatherapy-Yogatherapy group, Yogatherapy group |
Primary outcome
Change in frequence and intensity of hot flashes
Time frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Change in frequence and intensity of hot flashes using questionnaire developed for this study.
6 secondary outcomes
Change in quality of sleep
Time frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Body resonance
Time frame: Before intervention
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.
Personal data
Time frame: Before intervention
Change in stress level
Time frame: At beginning of study and after each session of intervention (twice a week for 10 weeks).
Change in quality of life
Time frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassandra S Lyra, MSc principal investigator
Doctoral student at Universidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory aromatherapy and Yogatherapy in people with Menopause and Hot Flashes, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequence and intensity of hot flashes (time frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.