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Aromatherapy for Anxiety and Self-esteem: Clinical Trial

Primary Purpose

Anxiety, Self Esteem

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Group 2
Intervention Group 1
Intervention Group 3
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Self-Esteem

Eligibility Criteria

34 Years - 53 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be an employee of the nursing team and not be on probation
  • accept make use gel or freshener containing essential oil or essence ylang ylang
  • respond Anxiety Inventory(STAI)and Self-esteem scale and present moderate, high or very high anxiety on the STAI, medium or low self-esteem on the scale Self-esteem
  • accept not wear perfume during the survey period
  • accept the smell of Ylang Ylang.

Exclusion Criteria:

  • Self reported Hypotension
  • Medical License or vacation during the period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Intervention Group 2

    Intervention Group 1

    Intervention Group 3

    Arm Description

    Individuals belonging to Group 2 received a bottle containing aromatic gel enriched with ylang ylang essence only in 2% concentration and used massage with essential oil 3 times a day: leaving home to go to work, leaving the shift and before bedtime. The points indicated were the two handles and the sternum. Gel was applied and massaged in a circular motion for 30 seconds.

    Individuals belonging to Group 1 received a bottle containing aromatic gel enriched with essential oil of ylang ylang in a concentration of 2% and used massage with essential oil 3 times a day: leaving home to go to work, leaving the shift and before bedtime. The points indicated were the two handles and the sternum. Gel was applied and massaged in a circular motion for 30 seconds.

    The subjects in Group 3 were responsible for before the beginning of their working, put a drop of essential oil of ylang ylang in cotton located within the freshener personal and should be used throughout your work shift

    Outcomes

    Primary Outcome Measures

    State-Trait Anxiety Inventory
    The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.

    Secondary Outcome Measures

    Self-Esteem Scale
    This is a unidimensional measure of self-esteem, which has 15 statements about the assessments that the subject makes about itself. For each statement, the subject chooses one of two options: agree or disagree. The level of self-esteem is provided through a template that assigns one point for each answer in agreement and zero points for each answer in disagreement. The maximum score is 15 points and the minimum is 0 points.

    Full Information

    First Posted
    October 13, 2013
    Last Updated
    October 13, 2013
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01963689
    Brief Title
    Aromatherapy for Anxiety and Self-esteem: Clinical Trial
    Official Title
    Aromatherapy for Anxiety and Self-esteem: Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (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 aim of this study was to determine whether the use of Ylang Ylang essential oil through dermal application or inhalation alters the perception of anxiety and self-esteem and physiological parameters such us blood pressure and temperature.
    Detailed Description
    34 nurses from the University Hospital participated in this study and were randomized into three groups: one that received the Ylang Ylang Essential Oil cutaneous route, the second received the Essential Oil inhalation and the third (placebo) received the essence of Ylang ylang cutaneous route.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Self Esteem
    Keywords
    Anxiety, Self-Esteem

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group 2
    Arm Type
    Placebo Comparator
    Arm Description
    Individuals belonging to Group 2 received a bottle containing aromatic gel enriched with ylang ylang essence only in 2% concentration and used massage with essential oil 3 times a day: leaving home to go to work, leaving the shift and before bedtime. The points indicated were the two handles and the sternum. Gel was applied and massaged in a circular motion for 30 seconds.
    Arm Title
    Intervention Group 1
    Arm Type
    Experimental
    Arm Description
    Individuals belonging to Group 1 received a bottle containing aromatic gel enriched with essential oil of ylang ylang in a concentration of 2% and used massage with essential oil 3 times a day: leaving home to go to work, leaving the shift and before bedtime. The points indicated were the two handles and the sternum. Gel was applied and massaged in a circular motion for 30 seconds.
    Arm Title
    Intervention Group 3
    Arm Type
    Experimental
    Arm Description
    The subjects in Group 3 were responsible for before the beginning of their working, put a drop of essential oil of ylang ylang in cotton located within the freshener personal and should be used throughout your work shift
    Intervention Type
    Other
    Intervention Name(s)
    Intervention Group 2
    Other Intervention Name(s)
    Massage, Aromatherapy
    Intervention Description
    Massage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area
    Intervention Type
    Other
    Intervention Name(s)
    Intervention Group 1
    Other Intervention Name(s)
    Massage, Aromatherapy
    Intervention Description
    Massage with Ylang Ylang essential oil in the wrist and in the region of the sternum
    Intervention Type
    Other
    Intervention Name(s)
    Intervention Group 3
    Other Intervention Name(s)
    Aromatherapy
    Intervention Description
    Put a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift
    Primary Outcome Measure Information:
    Title
    State-Trait Anxiety Inventory
    Description
    The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.
    Time Frame
    after 60 days
    Secondary Outcome Measure Information:
    Title
    Self-Esteem Scale
    Description
    This is a unidimensional measure of self-esteem, which has 15 statements about the assessments that the subject makes about itself. For each statement, the subject chooses one of two options: agree or disagree. The level of self-esteem is provided through a template that assigns one point for each answer in agreement and zero points for each answer in disagreement. The maximum score is 15 points and the minimum is 0 points.
    Time Frame
    after 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    34 Years
    Maximum Age & Unit of Time
    53 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: be an employee of the nursing team and not be on probation accept make use gel or freshener containing essential oil or essence ylang ylang respond Anxiety Inventory(STAI)and Self-esteem scale and present moderate, high or very high anxiety on the STAI, medium or low self-esteem on the scale Self-esteem accept not wear perfume during the survey period accept the smell of Ylang Ylang. Exclusion Criteria: Self reported Hypotension Medical License or vacation during the period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Júlia P da Silva
    Organizational Affiliation
    Nursing School of São Paulo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Aromatherapy for Anxiety and Self-esteem: Clinical Trial

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