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临床试验/NCT01816360
NCT01816360已完成不适用

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Change in frequence and intensity of hot flashes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age from 45 to 60 years
  • Women who reported having hot flashes for at least 6 months

排除标准

  • History of hysterectomy, oophorectomy or endometrial ablation
  • Chemotherapy in the last 5 years
  • Women receiving treatment for menopausal symptoms (including hormone replacement therapy)

结局指标

主要结局

Change in frequence and intensity of hot flashes

时间窗: 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.

次要结局

  • Change in quality of sleep(Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.)
  • Body resonance(Before intervention)
  • Psycho-social influences on the effects of the aroma.(Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.)
  • Personal data(Before intervention)
  • Change in stress level(At beginning of study and after each session of intervention (twice a week for 10 weeks).)
  • Change in quality of life(Before, after 10 sessions (5 weeks) and after 20 sessions (10 weeks) of intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cassandra Santantonio de Lyra, MSc

Master in Science

University of Sao Paulo

研究点 (1)

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