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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
Male or Female, aged 18 years and older
English or Spanish speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study 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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I speak English or Spanish.

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

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
450 Previous Clinical Trials
87,061 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA confirmed safety and efficacy of peppermint oil?

"Due to the lack of clinical evidence, Peppermint oil is assessed as being unsafe with a score of 1. This assessment takes into account its Phase 1 trial status and limited data surrounding efficacy and safety."

Answered by AI

Is there an open enrollment period for this research trial?

"Data hosted on clinicaltrials.gov reveals that this study is not open to recruitment at the moment, as it was last updated upon posting on May 16th 2022. However, 411 other medical trials are presently welcoming new participants."

Answered by AI
~9 spots leftby May 2024