Suffering, PhysicalPhase 1NCT05282706
Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
A Phase 1 study testing Lavender Oil, Mandarin Oil and Peppermint oil in people with Suffering, Physical and Nausea, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Use of inhaled essential oils to reduce the symptoms of pain or nausea, enabling a patient to have increase participation with PT or OT, thereby minimizing hospitalization-related risks and potentially reducing the length of stay in the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suffering, Physical, Nausea
- What is being tested?
- Lavender Oil, Mandarin Oil and Peppermint oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 3 Sep 2025
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients of acute care setting at University Health hospital
- Provision of a signed and dated informed consent form
- English or Spanish speaking
- Male or Female, aged 18 years and older
- Willing to comply with all study procedures
Who cannot join
- Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion
- Cognitive impairment
- Unable to communicate
- Admitted to the closed access unit or to psychiatry
- Allergic to lavender, mandarin or peppermint oil
- Diseases that cause olfactory disorders such as: COVID-19, benign growths or polyps, congestion from a cold, sinus infection or allergy flare-up
Show all 9Show fewer
- Drugs that may cause loss of the ability to smell e.g., intranasal zinc products, decongestant nose sprays and certain oral drugs such as nifedipine and phenothiazines
- Pregnant women (self-reported)
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled Clinical Trial Investigating the Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
Use of inhaled essential oils to reduce the symptoms of pain or nausea, enabling a patient to have increase participation with PT or OT, thereby minimizing hospitalization-related risks and potentially reducing the length of stay in the hospital.
Read the detailed description
The study intervention consists of 3 essential oils: lavender, mandarin and peppermint administered on an inhalation patch affixed in the chest region of the participant gown. The inhalation patch consists of hydrogel cast onto polyester film, supported by non-woven polyester fabric, covered with a polyethylene film. The proprietary foil-backed lamination on the patch is used to provide an occlusive barrier that prevents any essential oil from being absorbed through the skin. The placebo will consist of a comparable sized felt patch with adhesive backing with no essential oil applied.
- Conditions
- Suffering, Physical, Nausea
- Being tested
- Lavender Oil, Mandarin Oil, Peppermint oil, Placebo
- Keywords
- Acute Care, Physical Therapy, Occupational Therapy, Aromatherapy
- Medical subject headings
- Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDrug
Also called Lavender Aromatherapy Patch
A hydrogel lavender oil infused aromatherapy patch
Mandarin OilDrug
Also called Mandarin Aromatherapy Patch
A hydrogel mandarin oil infused aromatherapy patch
Peppermint oilDrug
Also called Peppermint Aromatherapy Patch
A hydrogel peppermint oil infused aromatherapy patch
PlaceboOther
Also called Placebo patch
A placebo patch containing no aromatherapy oil
| Study group | Role | What they receive |
|---|---|---|
| Pain Symptoms Arm | Experimental | Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session. Receives: Drug: Lavender Oil; Drug: Mandarin Oil |
| Nausea Symptom Arm | Experimental | Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session. Receives: Drug: Peppermint oil |
| Placebo Group | Placebo comparator | Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session. Receives: Other: Placebo |
| Standard of Care Group | No intervention | Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session that decline the option to use an aromatherapy patch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of PT/OT session
The number of subjects who successfully completed physical or occupational therapy session
Measured: 30 minutes
Secondary outcomes (1)
Change in Pain/Nausea Scale
A scale with ranks the pain or nausea from 0 to 10 with a 0 being no pain or nausea and 10 being the worst pain
Measured: Baseline to post therapy follow-up (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start16 May 2022
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suffering, PhysicalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three interventional and one control arm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Health
- Responsible party
- Sponsor
- Investigators
- Bianca Gonzales, OTR, CNT, EdD, MOT, Principal investigator, University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282706
- Sponsor's protocol ID
- HSC20210769H
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be registered on ClinicalTrials.gov and will be conducted in accordance with the ICMJE publication and data sharing policies and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Clinical Trial Investigating the Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting
- ClinicalTrials.gov ID
- NCT05282706
- Acronym / sponsor ID
- HSC20210769H
- Conditions
- Suffering, Physical, Nausea
- Keywords
- Acute Care, Physical Therapy, Occupational Therapy, Aromatherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- University Health
- Study start
- 16 May 2022 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 16 Mar 2022 (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.
Use of inhaled essential oils to reduce the symptoms of pain or nausea, enabling a patient to have increase participation with PT or OT, thereby minimizing hospitalization-related risks and potentially reducing the length of stay in the hospital.
Detailed description
The study intervention consists of 3 essential oils: lavender, mandarin and peppermint administered on an inhalation patch affixed in the chest region of the participant gown. The inhalation patch consists of hydrogel cast onto polyester film, supported by non-woven polyester fabric, covered with a polyethylene film. The proprietary foil-backed lamination on the patch is used to provide an occlusive barrier that prevents any essential oil from being absorbed through the skin. The placebo will consist of a comparable sized felt patch with adhesive backing with no essential oil applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Three interventional and one control arm
| Arm | Type | Receives |
|---|---|---|
| Pain Symptoms Arm | Experimental | Drug: Lavender Oil, Drug: Mandarin OilSubjects who will receive physical or occupational therapy experiencing pain prior to therapy session. |
| Nausea Symptom Arm | Experimental | Drug: Peppermint oilSubjects who will receive physical or occupational therapy experiencing nausea prior to therapy session. |
| Placebo Group | Placebo comparator | Other: PlaceboSubjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session. |
| Standard of Care Group | No intervention | –Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session that decline the option to use an aromatherapy patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients of acute care setting at University Health hospital
- Provision of a signed and dated informed consent form
- English or Spanish speaking
- Male or Female, aged 18 years and older
- Willing to comply with all study procedures
Key exclusion criteria (9 listed)
- Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion
- Cognitive impairment
- Unable to communicate
- Admitted to the closed access unit or to psychiatry
- Allergic to lavender, mandarin or peppermint oil
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 OilAlso: Lavender Aromatherapy PatchA hydrogel lavender oil infused aromatherapy patch | Drug | Pain Symptoms Arm |
| Mandarin OilAlso: Mandarin Aromatherapy PatchA hydrogel mandarin oil infused aromatherapy patch | Drug | Pain Symptoms Arm |
| Peppermint oilAlso: Peppermint Aromatherapy PatchA hydrogel peppermint oil infused aromatherapy patch | Drug | Nausea Symptom Arm |
| PlaceboAlso: Placebo patchA placebo patch containing no aromatherapy oil | Other | Placebo Group |
Primary outcome
Completion of PT/OT session
Time frame: 30 minutes
The number of subjects who successfully completed physical or occupational therapy session
1 secondary outcome
Change in Pain/Nausea Scale
Time frame: Baseline to post therapy follow-up (30 minutes)
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 16 Jun 2026.
- Individual participant dataSharing planned: Yes. The study will be registered on ClinicalTrials.gov and will be conducted in accordance with the ICMJE publication and data sharing policies and regulations.
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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.
Bianca Gonzales, OTR, CNT, EdD, MOT principal investigator
University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lavender Oil, Mandarin Oil and Peppermint oil in people with Suffering, Physical and Nausea, run by The University of Texas Health Science Center at San Antonio 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 5 inclusion and 9 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 16 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Completion of PT/OT session (time frame: 30 minutes). 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 16 Jun 2026.