Evaluation of the Efficacy of Aromatherapy on the Well-being of Healthcare Professionals

Study Overview
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Brief Summary
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The main objective is to evaluate the efficacy of aromatherapy (inhaler sticks) on the well-being of healthcare professionals practicing in medical and surgical intensive care unit, operating room/anesthesia and emergency departments

Detailed Description
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The secondary objectives of this study are : To evaluate the efficacy of aromatherapy on anxiety of healthcare professionals; To evaluate the efficacy of aromatherapy on stress symptoms of healthcate professionals; To assess compliance with aromatherapy. Conduct of research: All participants included in the study will receive the study treatment (essential oils mixtures in inhaler sticks for 2 months) and the control (no intervention for 2 months), in random order. At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.

Official Title
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Evaluation of the Efficacy of Aromatherapy on the Well-being of Hospital Healthcare Professionals: a Randomized Cross-over Trial

Conditions
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Healthcare Professionnals

Intervention / Treatment
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* Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2)
* Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare professional ; Working in a medical or surgical intensive care unit or in a operating room/anesthesia unit or in the emergency department; Agrees not to use any topical, oral or inhaled essential oils during the two study periods, other than those specified in the study protocol; Written informed consent; Exclusion Criteria: Pregnant or breastfeeding woman; Known allergies to essential oils; Asthma; Scheduled departure from the unit; Antidepressant treatment or anxiolytic treatment; Taking topical, oral or inhaled essential oils durink the week prior to inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatherapy first then no intervention<br>The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed | Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2)<br>* The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed<br>Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)<br>* The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.<br>|
| Experimental: No intervention first then Aromatherapy<br>The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed. | Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2)<br>* The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed<br>Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)<br>* The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization index of well-being | The World Health Organization well-being index consists of 5 items with 6 response modalities distributed on a frequency scale from 0 to 5. A global score is obtained by adding the answers to the 5 items, then multiplying this result by 4, i.e. a global score varying from 0 to 100. 0 is the worst score possible and 100 is the best score possible. | Through study completion, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spielberger General Anxiety Questionnaire | The Spielberger General Anxiety Questionnaire consists of 20 items with 4 response modalities distributed on a frequency scale from 1 to 4 (the scoring of some questions being reversed). A global score between 20 and 80 is obtained by adding the answers to the 20 items. For women the average score is 47.13.For men the average score is 39.27. A score above these averages indicates an anxious personality. The higher the score, the greater the anxiety. For men, a score higher than 51 indicates significant anxiety that interferes with quality of life. For women, a score higher than 61 indicates significant anxiety that interferes with quality of life. | Through study completion, 4 months | 
| Perceived Stress Scale | The Perceived Stress Scale is a 10-item scale with 5 response modalities distributed on a frequency scale from 0 to 4 (the scoring of some questions being reversed). A global score between 0 and 40 is obtained by adding the answers to the 10 items. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress | Through study completion, 4 months | 
| Follow-up diary | Compliance collected using a follow-up diary in which the participant will enter the average daily use of the rest stick and the work stick over the past week | End of aromatherapy, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, Aromatherapy, anxiety, quality of life, critical care