NCT01816360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

2.9 years

First QC Date

March 18, 2013

Last Update Submit

March 19, 2013

Conditions

MenopauseHot FlashesHot Flushes

Keywords

Womens healthMenopauseComplementary therapiesAromatherapyEssential oilsYogatherapyPsychoneuroendocrineimmunology

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (6)

  • 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).

  • +1 more secondary outcomes

Study Arms (4)

Aromatherapy group

EXPERIMENTAL

20 sessions of olfactory aromatherapy using protocol.

Other: Olfactory aromatherapy

Yogatherapy group

EXPERIMENTAL

20 sessions of yogatherapy with aroma-placebo using protocol.

Other: Yogatherapy

Aromatherapy-Yogatherapy group

EXPERIMENTAL

20 sessions of yogatherapy with olfactory aromatherapy, using protocol.

Other: Olfactory aromatherapyOther: Yogatherapy

Control group

NO INTERVENTION

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

Interventions

Olfactory aromatherapyOTHER

Inhalation of essential oils.

Aromatherapy groupAromatherapy-Yogatherapy group
YogatherapyOTHER

Yogatherapy respiratory exercises.

Aromatherapy-Yogatherapy groupYogatherapy group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cassandra S Lyra, MSc

    Doctoral student at Universidade de Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Science

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 22, 2013

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

BR(1)