NCT07328412

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 1, 2025

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Acceptability of intervention via AIM

    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

    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

Study Arms (2)

Aromatherapy Group

EXPERIMENTAL

Participants will receive a lavender-scented tube to inhale for 5 minutes.

Other: Lavender Aromatherapy

Control Group

ACTIVE COMPARATOR

Participants will receive an unscented tube to inhale for 5 minutes.

Other: Unscented Aromatherapy

Interventions

A diffuser tube containing a cotton wick infused with 5 drops of lavender essential oil.

Aromatherapy Group

A diffuser tube containing a cotton wick saturated with 10 drops of water.

Control Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Anxiety DisordersEmergencies

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Chai, MD, MMS

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2025

First Posted

January 9, 2026

Study Start

February 2, 2026

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations