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NCT Number: NCT05373849

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

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

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Key information

Conditions

Healthcare Professionnals Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHRMSA

Mulhouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2)

Dietary Supplement

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 (step 1) - essential oils mixture in inhaler sticks (step 2)

Dietary Supplement

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 outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study title

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

Acronym: HERBAS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2022
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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