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Aromatherapy for Pain and Nausea in Acute Care Therapy

Phase 1
Waitlist Available
Led By Bianca Gonzales, OTR, CNT, EdD, MOT
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion
Admitted to the closed access unit or to psychiatry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Summary

This trial found that using inhaled essential oils reduced symptoms of pain or nausea, allowing patients to participate more in PT or OT, and potentially reducing their time in the hospital.

Who is the study for?
This trial is for adult patients in an acute care setting at University Health hospital who can consent and communicate in English or Spanish. They should be willing to follow the study procedures but cannot have respiratory disorders, cognitive impairments, olfactory issues, allergies to essential oils used in the study, or be pregnant or imprisoned.Check my eligibility
What is being tested?
The trial tests if inhaling essential oils like peppermint oil, lavender oil, and mandarin oil can reduce pain or nausea compared to a placebo. This could help patients participate more in physical/occupational therapy and possibly shorten their hospital stay.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the oils such as skin irritation or worsening of asthma symptoms for those sensitive to aromas. However, these are typically mild.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a lung condition such as asthma, COPD, or lung cancer.
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I am currently admitted to a closed access unit or psychiatry ward.
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I have difficulty with memory or thinking clearly.
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I cannot communicate effectively.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion of PT/OT session
Secondary outcome measures
Change in Pain/Nausea Scale
Other outcome measures
Increase in participation in PT and OT sessions

Side effects data

From 2015 Phase 2 trial • 8 Patients • NCT02291445
25%
Headache
25%
Altered Fecal Odor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ileocolonic Release PO
Small Intestinal Release PO

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Pain Symptoms ArmExperimental Treatment2 Interventions
Subjects who will receive physical or occupational therapy experiencing pain prior to therapy session.
Group II: Nausea Symptom ArmExperimental Treatment1 Intervention
Subjects who will receive physical or occupational therapy experiencing nausea prior to therapy session.
Group III: Standard of Care GroupActive Control1 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.
Group IV: Placebo GroupPlacebo Group1 Intervention
Subjects who will receive physical or occupational therapy experiencing pain or nausea prior to therapy session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peppermint oil
2018
Completed Phase 1
~230
Lavender Oil
2017
Completed Phase 1
~530

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Non-pharmacological treatments for pain, such as inhaled essential oils, reflexology, acupuncture, and therapeutic touch, work through various mechanisms. Inhaled essential oils, used in aromatherapy, may alleviate pain and nausea by stimulating the olfactory system, which can influence brain regions involved in emotion and pain perception. Reflexology and therapeutic touch aim to reduce pain by promoting relaxation and improving circulation, potentially altering pain signaling pathways. Acupuncture involves inserting needles at specific points to release endorphins and modulate pain through neural pathways. These treatments are important for pain patients as they offer alternative or complementary options to pharmacological therapies, potentially reducing medication side effects and improving overall quality of life.
The landscape of pain management in people with dementia living in care homes: a mixed methods study.A systematic review: non-pharmacological interventions in treating pain in patients with advanced cancer.

Find a Location

Who is running the clinical trial?

University HealthUNKNOWN
1 Previous Clinical Trials
360 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
457 Previous Clinical Trials
91,401 Total Patients Enrolled
4 Trials studying Pain
2,461 Patients Enrolled for Pain
University HospitalOTHER
2 Previous Clinical Trials
193 Total Patients Enrolled

Media Library

Peppermint oil Clinical Trial Eligibility Overview. Trial Name: NCT05282706 — Phase 1
Pain Research Study Groups: Nausea Symptom Arm, Pain Symptoms Arm, Placebo Group, Standard of Care Group
Pain Clinical Trial 2023: Peppermint oil Highlights & Side Effects. Trial Name: NCT05282706 — Phase 1
Peppermint oil 2023 Treatment Timeline for Medical Study. Trial Name: NCT05282706 — Phase 1
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