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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05910892
Other study ID # STUDY00007869
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date September 30, 2023

Study information

Verified date June 2023
Source University of Washington
Contact Lisa Y Flint
Phone 206 543-7817
Email lyflint@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date September 30, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Aromatherapy packet
5 deep breaths from packet prior to treatment
Placebo packet
5 deep breaths from packet prior to treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Acute Pain 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 Change in Overall Experience 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
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