Aromatherapy and Pain

June 17, 2023 updated by: Heather Tick, University of Washington

The Effect of Aromatherapy on the Incidence and Severity of Post Procedure Pain and Discomfort in Patients

Effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will explore the effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain. This will be a blinded study where patients will act as their own control over two treatment visits. On one visit patient will be exposed to either the aromatherapy or a placebo. On their second visit patients will be exposed to the other compound. The study will collect demographic data, pain intensity and affect, and catastrophizing information.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have received at least one (1) prior IMS or trigger point injection treatment with researcher
  • 18 years of age or older
  • English language speaker
  • has completed Pain Tracker (clinic standard of care) questionnaire prior to study visit
  • any analgesic medication taken must be consistent for both sessions

Exclusion Criteria:

  • Non-English language speaker
  • Age <18
  • Allergy to essential oils
  • Asthmatic
  • Patient unable to self-administer aromatherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aromatherapy before treatment
Subject receives aromatherapy before IMS treatment or trigger point injection
Drug: Aromatherapy packet
5 deep breaths from packet prior to treatment
Other Names:
  • Aromatherapy
Placebo Comparator: Placebo before treatment
Subject receives placebo before IMS treatment or trigger point injection
Drug: Placebo packet
5 deep breaths from packet prior to treatment
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Acute Pain
Time Frame: Immediately after the Procedure
Examine the change in Acute Pain associated with two identical procedures involving muscle with either an aromatherapy intervention or control intervention. With each patient being their own control, patients will rate their acute pain immediately after the procedure on a 0-10 scale (0=No pain and 10=Pain as bad as you can imagine).
Immediately after the Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Overall Experience
Time Frame: Immediately after the Procedure
Examine the change in Overall Experience of pain with two identical procedures involving muscle with either an aromatherapy intervention or control intervention. With each patient being their own control, patients will rate their overall experience of pain after the procedure on a 0-10 scale (0=No pain and 10=Pain as bad as you can imagine).
Immediately after the Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Heather Tick, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

April 29, 2023

First Submitted That Met QC Criteria

June 17, 2023

First Posted (Actual)

June 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 20, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007869

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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