Aromatherapy and Yogatherapy for Hot Flashes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cassandra Santantonio de Lyra, MSc, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01816360
First received: March 18, 2013
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Menopause
Hot Flashes
Hot Flushes
Other: Olfactory aromatherapy
Other: Yogatherapy

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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in frequence and intensity of hot flashes [ Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention. ] [ Designated as safety issue: No ]
    Change in frequence and intensity of hot flashes using questionnaire developed for this study.


Secondary Outcome Measures:
  • Change in quality of sleep [ Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention. ] [ Designated as safety issue: No ]
    Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.

  • Body resonance [ Time Frame: Before intervention ] [ Designated as safety issue: No ]
    Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.

  • 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. ] [ Designated as safety issue: No ]
    Influence of aroma preferences and olfactory memories in effects of aroma. Changes in aroma preferences. Using questionnaire developed for this study.

  • Personal data [ Time Frame: Before intervention ] [ Designated as safety issue: No ]
    Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.

  • Change in stress level [ Time Frame: At beginning of study and after each session of intervention (twice a week for 10 weeks). ] [ Designated as safety issue: No ]
    Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.

  • Change in quality of life [ Time Frame: Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention. ] [ Designated as safety issue: No ]
    Change in quality of life measured by the SF-36 questionnaire.


Enrollment: 108
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aromatherapy group
20 sessions of olfactory aromatherapy using protocol.
Other: Olfactory aromatherapy
Inhalation of essential oils.
Experimental: Yogatherapy group
20 sessions of yogatherapy with aroma-placebo using protocol.
Other: Yogatherapy
Yogatherapy respiratory exercises.
Experimental: Aromatherapy-Yogatherapy group
20 sessions of yogatherapy with olfactory aromatherapy, using protocol.
Other: Olfactory aromatherapy
Inhalation of essential oils.
Other: Yogatherapy
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).

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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816360

Locations
Brazil
Universidade de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Cassandra S Lyra, MSc Doctoral student at Universidade de Sao Paulo
  More Information

No publications provided

Responsible Party: Cassandra Santantonio de Lyra, MSc, Master in Science, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01816360     History of Changes
Other Study ID Numbers: AromaYoga
Study First Received: March 18, 2013
Last Updated: March 19, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Womens health
Menopause
Complementary therapies
Aromatherapy
Essential oils
Yogatherapy
Psychoneuroendocrineimmunology

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014