AromatherapyNCT07328412
Aromatherapy to Address Psychological Distress in Emergency Department Patients.
A study testing Lavender Aromatherapy and Unscented Aromatherapy in people with Aromatherapy and Anxiety, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aromatherapy, Anxiety, Stress
- What is being tested?
- Lavender Aromatherapy and Unscented Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Aromatherapy, Anxiety, Stress, Emergency Department
- Being tested
- Lavender Aromatherapy, Unscented Aromatherapy
- Medical subject headings
- Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender AromatherapyOther
A diffuser tube containing a cotton wick infused with 5 drops of lavender essential oil.
Unscented AromatherapyOther
A diffuser tube containing a cotton wick saturated with 10 drops of water.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy Group | Experimental | Participants will receive a lavender-scented tube to inhale for 5 minutes. Receives: Other: Lavender Aromatherapy |
| Control Group | Active comparator | Participants will receive an unscented tube to inhale for 5 minutes. Receives: Other: Unscented Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start2 Feb 2026
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter R Chai MD, Brigham and Women's Hospital
- Investigators
- Peter Chai, MD, MMS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328412
- Sponsor's protocol ID
- 2025P002810
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy to Address Psychological Distress in Emergency Department Patients.
- ClinicalTrials.gov ID
- NCT07328412
- Acronym / sponsor ID
- 2025P002810
- Conditions
- Aromatherapy, Anxiety, Stress, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy Group | Experimental | Other: Lavender AromatherapyParticipants will receive a lavender-scented tube to inhale for 5 minutes. |
| Control Group | Active comparator | Other: Unscented AromatherapyParticipants will receive an unscented tube to inhale for 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender AromatherapyA diffuser tube containing a cotton wick infused with 5 drops of lavender essential oil. | Other | Aromatherapy Group |
| Unscented AromatherapyA diffuser tube containing a cotton wick saturated with 10 drops of water. | Other | Control Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Chai, MD, MMS principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Aromatherapy and Unscented Aromatherapy in people with Aromatherapy and Anxiety, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention via AIM (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.