NCT01963689

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable anxiety

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

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

October 13, 2013

Last Update Submit

October 13, 2013

Conditions

Keywords

AnxietySelf-Esteem

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 60 days

Secondary Outcomes (1)

  • Self-Esteem Scale

    after 60 days

Study Arms (3)

Intervention Group 2

PLACEBO COMPARATOR

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.

Other: Intervention Group 2

Intervention Group 1

EXPERIMENTAL

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.

Other: Intervention Group 1

Intervention Group 3

EXPERIMENTAL

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

Other: Intervention Group 3

Interventions

Massage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area

Also known as: Massage, Aromatherapy
Intervention Group 2

Massage with Ylang Ylang essential oil in the wrist and in the region of the sternum

Also known as: Massage, Aromatherapy
Intervention Group 1

Put a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift

Also known as: Aromatherapy
Intervention Group 3

Eligibility Criteria

Age34 Years - 53 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

MassageAromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body TherapiesPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maria Júlia P da Silva

    Nursing School of São Paulo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Juliana Rizzo Gnatta

Study Record Dates

First Submitted

October 13, 2013

First Posted

October 16, 2013

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10