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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Brazil1 site
  • Universidade de São Paulo

    São Paulo, São Paulo

Other trials in Brazil

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.

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 groups in NCT01816360
Study groupRoleWhat they receive
Aromatherapy groupExperimental20 sessions of olfactory aromatherapy using protocol.
Receives: Other: Olfactory aromatherapy
Yogatherapy groupExperimental20 sessions of yogatherapy with aroma-placebo using protocol.
Receives: Other: Yogatherapy
Aromatherapy-Yogatherapy groupExperimental20 sessions of yogatherapy with olfactory aromatherapy, using protocol.
Receives: Other: Olfactory aromatherapy; Other: Yogatherapy
Control groupNo interventionControl 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.

  1. 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)
  1. 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.

  2. Body resonance

    Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.

    Measured: Before intervention

  3. 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.

  4. Personal data

    Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.

    Measured: Before intervention

  5. 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).

  6. 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.

  1. First posted22 Mar 2013 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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)
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

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.

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