Aromatherapy and Yogatherapy for Hot Flashes

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816360
• Other study ID #: AromaYoga
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: March 19, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hot Flashes
• Hot Flushes
• Menopause

Intervention

Other:
• Olfactory aromatherapy
Inhalation of essential oils.
• Yogatherapy
Yogatherapy respiratory exercises.

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequence and intensity of hot flashes	Change in frequence and intensity of hot flashes using questionnaire developed for this study.	Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.	No
Secondary	Change in quality of sleep	Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.	Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.	No
Secondary	Body resonance	Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.	Before intervention	No
Secondary	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.	Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.	No
Secondary	Personal data	Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.	Before intervention	No
Secondary	Change in stress level	Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.	At beginning of study and after each session of intervention (twice a week for 10 weeks).	No
Secondary	Change in quality of life	Change in quality of life measured by the SF-36 questionnaire.	Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.	No