AnxietyNCT01963689
Aromatherapy for Anxiety and Self-esteem: Clinical Trial
A study testing Intervention Group 2, Intervention Group 1 and Intervention Group 3 in people with Anxiety and Self Esteem, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Self Esteem
- What is being tested?
- Intervention Group 2, Intervention Group 1 and Intervention Group 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Self reported Hypotension
- Medical License or vacation during the period
About this study
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.
Read the 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.
- Conditions
- Anxiety, Self Esteem
- Being tested
- Intervention Group 2, Intervention Group 1, Intervention Group 3
- Keywords
- Anxiety, Self-Esteem
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group 2Other
Also called Massage, Aromatherapy
Massage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area
Intervention Group 1Other
Also called Massage, Aromatherapy
Massage with Ylang Ylang essential oil in the wrist and in the region of the sternum
Intervention Group 3Other
Also called Aromatherapy
Put a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Intervention Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 60 days
Secondary outcomes (1)
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.
Measured: after 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Rizzo Gnatta, University of Sao Paulo
- Investigators
- Maria Júlia P da Silva, Principal investigator, Nursing School of São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963689
- Sponsor's protocol ID
- 469376
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Anxiety and Self-esteem: Clinical Trial
- ClinicalTrials.gov ID
- NCT01963689
- Acronym / sponsor ID
- 469376
- Conditions
- Anxiety, Self Esteem
- Keywords
- Anxiety, Self-Esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 2 | Placebo comparator | Other: Intervention Group 2Individuals 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. |
| Intervention Group 1 | Experimental | Other: Intervention Group 1Individuals 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. |
| Intervention Group 3 | Experimental | Other: Intervention Group 3The 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 |
Who may qualify
- Ages
- 34 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Self reported Hypotension
- Medical License or vacation during the period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group 2Also: Massage, AromatherapyMassage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area | Other | Intervention Group 2 |
| Intervention Group 1Also: Massage, AromatherapyMassage with Ylang Ylang essential oil in the wrist and in the region of the sternum | Other | Intervention Group 1 |
| Intervention Group 3Also: AromatherapyPut a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift | Other | Intervention Group 3 |
Primary outcome
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.
1 secondary outcome
Self-Esteem Scale
Time frame: after 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Júlia P da Silva principal investigator
Nursing School of São Paulo University
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group 2, Intervention Group 1 and Intervention Group 3 in people with Anxiety and Self Esteem, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: after 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.