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Completed

NCT Number: NCT01816360

Aromatherapy and Yogatherapy for Hot Flashes

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.

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Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de São Paulo

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olfactory aromatherapy

Other

Inhalation of essential oils.

Yogatherapy

Other

Yogatherapy respiratory exercises.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in quality of sleep

    Time frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.

    Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.

  2. Body resonance

    Time frame: Before intervention

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

  3. 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.

    Influence of aroma preferences and olfactory memories in effects of aroma. Changes in aroma preferences. Using questionnaire developed for this study.

  4. Personal data

    Time frame: Before intervention

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

  5. Change in stress level

    Time frame: At beginning of study and after each session of intervention (twice a week for 10 weeks).

    Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.

  6. Change in quality of life

    Time frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.

    Change in quality of life measured by the SF-36 questionnaire.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2013
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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