Evaluation of the Efficacy of Aromatherapy on the Well-being of Healthcare Professionals (HERBAS)

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

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

Study Overview

• Status: Completed
• Conditions: Healthcare Professionnals
• Intervention / Treatment: 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)

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Florence DUREAU, PI; Phone Number: +33 389648308; Email: anne-florence.dureau@ghrmsa.fr

Study Locations

• France
  • Mulhouse, France
    • GHRMSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: critical care; quality of life; anxiety; stress; Aromatherapy
• Other Study ID Numbers: GHRMSA 1192; 2021-A02995-36 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No