- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01963689
Aromatherapy for Anxiety and Self-esteem: Clinical Trial
October 13, 2013 updated by: Juliana Rizzo Gnatta, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
34 years to 53 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Intervention Group 2
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.
|
Massage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area
Other Names:
|
Experimental: Intervention Group 1
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.
|
Massage with Ylang Ylang essential oil in the wrist and in the region of the sternum
Other Names:
|
Experimental: Intervention Group 3
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
|
Put a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State-Trait Anxiety Inventory
Time Frame: after 60 days
|
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.
|
after 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Esteem Scale
Time Frame: after 60 days
|
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.
|
after 60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Júlia P da Silva, Nursing School of São Paulo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
October 13, 2013
First Submitted That Met QC Criteria
October 13, 2013
First Posted (Estimate)
October 16, 2013
Study Record Updates
Last Update Posted (Estimate)
October 16, 2013
Last Update Submitted That Met QC Criteria
October 13, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 469376
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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