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

Not Applicable

Completed

• Conditions: Healthcare Professionnals
• Interventions: 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)

• Registration Number: NCT05373849
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-05-04
• Study Start: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aromatherapy first then no intervention	no intervention (step 1) - essential oils mixture in inhaler sticks (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
Aromatherapy first then no intervention	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
No intervention first then Aromatherapy	essentiel oil mixtures in inhaler sticks (step 1) - no intervention (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.
No intervention first then Aromatherapy	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.

Primary Outcome Measures

Name	Time	Method
World Health Organization index of well-being	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 Outcome Measures

Name	Time	Method
Spielberger General Anxiety Questionnaire	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.
Follow-up diary	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
Perceived Stress Scale	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

Trial Locations

Locations (1)

GHRMSA; 🇫🇷 Mulhouse, France