What side effects are associated with this type of intervention?

Common treatments for pain, particularly non-pharmacological interventions like inhaled essential oils, generally have minimal side effects. Aromatherapy, for instance, has been shown to reduce pain perception with few reported adverse effects. However, some individuals may experience mild side effects such as headache, nausea, or dizziness. Overall, these treatments are considered safe and well-tolerated, making them a viable complementary option for pain management.

What prior FDA approvals exist?

The FDA has approved various treatments for pain management, including pharmacologic options like opioids, NSAIDs, and adjuvant analgesics such as gabapentin and duloxetine. While inhaled essential oils for pain and nausea relief are being studied, they are not yet FDA-approved for these indications. However, aromatherapy has shown promise in reducing pain perception in clinical settings, suggesting potential future applications pending further research and regulatory approval.

What other types of research exist?

Promising novel alternatives to inhaled essential oils for pain and nausea relief in 2024 include: 1) Cannabinoids: While evidence is mixed, some studies suggest potential benefits for chronic pain relief, especially neuropathic pain. 2) Topical Capsaicin: Effective for conditions like cannabinoid hyperemesis syndrome, it may also help with other types of pain. 3) Integrative Therapies: Techniques such as Reiki, therapeutic touch, and healing touch have shown potential benefits for pain management. 4) Physical Exercise: Regular physical activity and specific exercises can help manage chronic pain and improve quality of life. 5) Aromatherapy with Lavender: Specifically shown to reduce postoperative pain intensity. These alternatives should be discussed with a healthcare provider to tailor the best approach for individual patient needs.

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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 uses patches with essential oils to help patients with pain or nausea. The oils are inhaled to reduce symptoms, making it easier for patients to participate in therapy and potentially shorten their hospital stay. Essential oils have been used in aromatherapy to alleviate anxiety symptoms and have shown minimal adverse effects in studies.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion of PT/OT session

Secondary study objectives

Change in Pain/Nausea Scale

Other study objectives

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%

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

0 / 4Eligibility criteria met

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.