Aromatherapy to Address Psychological Distress in Emergency Department Patients.

April 23, 2026 updated by: Peter R Chai MD, Brigham and Women's Hospital
The goal of this clinical trial is to understand the feasibility and acceptability of a brief aromatherapy session for reducing stress, anxiety, and improving patient satisfaction among emergency department patients. The main question the study aims to answer is: Is the intervention acceptable and feasible? Participants in the intervention group will receive a lavender-scented tube and smell it for about 5 minutes. Participants in the control group will receive an unscented tube and follow the same instructions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stress and anxiety are frequently experienced by patients during emergency department (ED) visits, often due to diagnostic uncertainty, prolonged wait times, and environmental factors such as noise and bright lighting. These psychological stressors can trigger physiological responses, including elevated cortisol levels, increased blood pressure, and disrupted sleep, which may negatively impact patients' experiences and overall health outcomes. Aromatherapy has emerged as a promising non-pharmacologic intervention for reducing stress and anxiety in various settings.

This pilot randomized controlled trial will be conducted to assess the feasibility and acceptability of a brief aromatherapy session for ED patients. Research staff will pre-screen potential participants admitted to the ED Observation Unit at Brigham and Women's Hospital (BWH) using information from the electronic medical record. After obtaining approval from the treating medical team, staff will approach and invite potential participants to participate in the study. Once consented and screened eligible, participants will complete a baseline assessment and be randomized in a 1:1 ratio to either the aromatherapy group or the control group. Participants in the aromatherapy group will receive a lavender-scented tube and be instructed to inhale it for about 5 minutes. Participants in the control group will receive an unscented tube and follow the same instructions. After the session, participants will complete a post-experiment assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults ≥18 years of age
  • Admitted to the BWH Emergency Department (ED) Observation Unit
  • Able to provide written informed consent
  • Willing to participate in a 1-hour aromatherapy session

Exclusion Criteria:

  • Acutely ill and unable to be approached for research, as determined by the treating medical team and/or physician investigator
  • Active gastrointestinal problems at the time of enrollment (e.g., nausea, vomiting, abdominal cramping, diarrhea), as determined by the treating team and/or physician investigator.
  • Pregnancy or breastfeeding
  • Current or planned treatment using sedating medications
  • History of, or current presentation with, significant cognitive impairment or acute delirium that would preclude informed consent or participation
  • Currently receiving supplemental oxygen
  • Acute exacerbation of asthma or COPD
  • Admission for an acute upper or lower respiratory tract illness (e.g., pneumonia, bronchitis, influenza, COVID-19)
  • Known allergy or sensitivity to lavender
  • Documented history of anosmia (loss of smell)
  • Documented hypotension during current ED presentation, defined as systolic blood pressure <90 mmHg
  • Assigned clinical staff (physician, nurse, or other healthcare provider) with fragrance sensitivity prior to consent
  • Concurrent enrollment in another interventional drug or behavioral trial
  • Any condition that, in the judgment of the treating team or physician investigator, would make study participation unsafe or inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aromatherapy Group
Participants will receive a lavender-scented tube to inhale for 5 minutes.
Other: Lavender Aromatherapy
A diffuser tube containing a cotton wick infused with 5 drops of lavender essential oil.
Active Comparator: Control Group
Participants will receive an unscented tube to inhale for 5 minutes.
Other: Unscented Aromatherapy
A diffuser tube containing a cotton wick saturated with 10 drops of water.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of intervention via AIM
Time Frame: day 1
Acceptability will be assessed via the Acceptability of Intervention Measure (AIM). AIM is a 4-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated, resulting in a continuous score with higher scores indicating greater intervention acceptability.
day 1
Usability of intervention via SUS
Time Frame: day 1
Usability will be assessed via an adapted, validated 2-item version of the System Usability Scale (SUS). Each item is rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). The mean score of each item will be calculated and entered into a validated regression equation to estimate the full SUS score, which ranges from 0 to 100, with higher scores indicating greater usability.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Chai, MD, MMS, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025P002810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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