search
Back to results

Aromatherapy and Yogatherapy for Hot Flashes

Primary Purpose

Menopause, Hot Flashes, Hot Flushes

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Olfactory aromatherapy
Yogatherapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Menopause focused on measuring Womens health, Menopause, Complementary therapies, Aromatherapy, Essential oils, Yogatherapy, Psychoneuroendocrineimmunology

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Aromatherapy group

Yogatherapy group

Aromatherapy-Yogatherapy group

Control group

Arm Description

20 sessions of olfactory aromatherapy using protocol.

20 sessions of yogatherapy with aroma-placebo using protocol.

20 sessions of yogatherapy with olfactory aromatherapy, using protocol.

Control group in the waiting-list model (all volunteers were offered the treatment after the completion of data collection).

Outcomes

Primary Outcome Measures

Change in frequence and intensity of hot flashes
Change in frequence and intensity of hot flashes using questionnaire developed for this study.

Secondary Outcome Measures

Change in quality of sleep
Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.
Body resonance
Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.
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.
Personal data
Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.
Change in stress level
Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.
Change in quality of life
Change in quality of life measured by the SF-36 questionnaire.

Full Information

First Posted
March 18, 2013
Last Updated
March 19, 2013
Sponsor
University of Sao Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01816360
Brief Title
Aromatherapy and Yogatherapy for Hot Flashes
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Hot Flashes, Hot Flushes
Keywords
Womens health, Menopause, Complementary therapies, Aromatherapy, Essential oils, Yogatherapy, Psychoneuroendocrineimmunology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aromatherapy group
Arm Type
Experimental
Arm Description
20 sessions of olfactory aromatherapy using protocol.
Arm Title
Yogatherapy group
Arm Type
Experimental
Arm Description
20 sessions of yogatherapy with aroma-placebo using protocol.
Arm Title
Aromatherapy-Yogatherapy group
Arm Type
Experimental
Arm Description
20 sessions of yogatherapy with olfactory aromatherapy, using protocol.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group in the waiting-list model (all volunteers were offered the treatment after the completion of data collection).
Intervention Type
Other
Intervention Name(s)
Olfactory aromatherapy
Intervention Description
Inhalation of essential oils.
Intervention Type
Other
Intervention Name(s)
Yogatherapy
Intervention Description
Yogatherapy respiratory exercises.
Primary Outcome Measure Information:
Title
Change in frequence and intensity of hot flashes
Description
Change in frequence and intensity of hot flashes using questionnaire developed for this study.
Time Frame
Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Secondary Outcome Measure Information:
Title
Change in quality of sleep
Description
Change in quality of sleep using the Pittsburgh Index of Quality of Sleep, translated to portuguese.
Time Frame
Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Title
Body resonance
Description
Body resonance using the "RESCORP" (ressonância corporal) brazilian questionnaire.
Time Frame
Before intervention
Title
Psycho-social influences on the effects of the aroma.
Description
Influence of aroma preferences and olfactory memories in effects of aroma. Changes in aroma preferences. Using questionnaire developed for this study.
Time Frame
Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.
Title
Personal data
Description
Personal data for evaluating possible correlations and verifying possible risk factors for climacteric symptoms.
Time Frame
Before intervention
Title
Change in stress level
Description
Change in stress level throughout the whole 20 sessions of intervention, using the Visual Analogue Scale for Stress.
Time Frame
At beginning of study and after each session of intervention (twice a week for 10 weeks).
Title
Change in quality of life
Description
Change in quality of life measured by the SF-36 questionnaire.
Time Frame
Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra S Lyra, MSc
Organizational Affiliation
Doctoral student at Universidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Aromatherapy and Yogatherapy for Hot Flashes

We'll reach out to this number within 24 hrs