NCT05373849

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

May 4, 2022

Last Update Submit

October 27, 2023

Conditions

Healthcare Professionnals

Keywords

Aromatherapystressanxietyquality of lifecritical care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Spielberger General Anxiety Questionnaire

    Through study completion, 4 months

  • Perceived Stress Scale

    Through study completion, 4 months

  • Follow-up diary

    End of aromatherapy, 2 months

Study Arms (2)

Aromatherapy first then no intervention

EXPERIMENTAL

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)Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)

No intervention first then Aromatherapy

EXPERIMENTAL

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)Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)

Interventions

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

Aromatherapy first then no interventionNo intervention first then Aromatherapy
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.

Aromatherapy first then no interventionNo intervention first then Aromatherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Pregnant or breastfeeding woman;
  • Known allergies to essential oils;
  • Asthma;
  • Scheduled departure from the unit;
  • Antidepressant treatment or anxiolytic treatment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHRMSA

Mulhouse, France

Location

Related Publications (1)

  • Anne-Florence D, Samuel D, Cindy P, Marie D, Clement P. The Efficacy of Aromatherapy on Well-Being and Stress. Nurs Crit Care. 2026 Jan;31(1):e70270. doi: 10.1111/nicc.70270.

    PMID: 41330862DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 13, 2022

Study Start

May 9, 2022

Primary Completion

April 27, 2023

Study Completion

April 27, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

FR(1)