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

Overview

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

Full Title of Study: “Evaluation of the Efficacy of Aromatherapy on the Well-being of Hospital Healthcare Professionals: a Randomized Cross-over Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2023

Detailed Description

The secondary objectives of this study are : 1. To evaluate the efficacy of aromatherapy on anxiety of healthcare professionals; 2. To evaluate the efficacy of aromatherapy on stress symptoms of healthcate professionals; 3. 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.

Interventions

  • Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) – no intervention (step 2)
    • 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: no intervention (step 1) – essential oils mixture in inhaler sticks (step 2)
    • 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.

Arms, Groups and Cohorts

  • Experimental: Aromatherapy first then no intervention
    • 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
  • Experimental: No intervention first then Aromatherapy
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • World Health Organization index of well-being
    • Time Frame: Through study completion, 4 months
    • 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.

Secondary Measures

  • Spielberger General Anxiety Questionnaire
    • Time Frame: Through study completion, 4 months
    • 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.
  • Perceived Stress Scale
    • Time Frame: Through study completion, 4 months
    • 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
  • Follow-up diary
    • Time Frame: End of aromatherapy, 2 months
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Anne-Florence DUREAU, PI, +33 389648308, anne-florence.dureau@ghrmsa.fr

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