Back to resultsAromatherapy and Pain
Primary Purpose
Chronic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aromatherapy packet
Placebo packet
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Pain focused on measuring Intramuscular Stimulation Therapy, Trigger Point Injections, Aromatherapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aromatherapy before treatment
Placebo before treatment
Arm Description
Subject receives aromatherapy before IMS treatment or trigger point injection
Subject receives placebo before IMS treatment or trigger point injection
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05910892
Brief Title
Aromatherapy and Pain
Official Title
The Effect of Aromatherapy on the Incidence and Severity of Post Procedure Pain and Discomfort in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Intramuscular Stimulation Therapy, Trigger Point Injections, Aromatherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aromatherapy before treatment
Arm Type
Active Comparator
Arm Description
Subject receives aromatherapy before IMS treatment or trigger point injection
Arm Title
Placebo before treatment
Arm Type
Placebo Comparator
Arm Description
Subject receives placebo before IMS treatment or trigger point injection
Intervention Type
Drug
Intervention Name(s)
Aromatherapy packet
Other Intervention Name(s)
Aromatherapy
Intervention Description
5 deep breaths from packet prior to treatment
Intervention Type
Drug
Intervention Name(s)
Placebo packet
Other Intervention Name(s)
Placebo
Intervention Description
5 deep breaths from packet prior to treatment
Primary Outcome Measure Information:
Title
Change in Acute Pain
Description
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).
Time Frame
Immediately after the Procedure
Secondary Outcome Measure Information:
Title
Change in Overall Experience
Description
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).
Time Frame
Immediately after the Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Y Flint
Phone
206 543-7817
Email
lyflint@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Tick, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Aromatherapy and Pain
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