Aromatherapy and Pain

NCT05910892 | Withdrawn

• 1 other identifier: STUDY00007869
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Pain

Keywords

Intramuscular Stimulation Therapy; Trigger Point Injections; Aromatherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Overall Experience

  Immediately after the Procedure

Study Arms (2)

Aromatherapy before treatment

ACTIVE COMPARATOR

Subject receives aromatherapy before IMS treatment or trigger point injection

Drug: Aromatherapy packet

Placebo before treatment

PLACEBO COMPARATOR

Subject receives placebo before IMS treatment or trigger point injection

Drug: Placebo packet

Interventions

Aromatherapy packet DRUG

5 deep breaths from packet prior to treatment

Also known as: Aromatherapy

Aromatherapy before treatment

Placebo packet DRUG

5 deep breaths from packet prior to treatment

Also known as: Placebo

Placebo before treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have received at least one (1) prior IMS or trigger point injection treatment with researcher
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Heather Tick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor: School of Medicine

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: June 20, 2023
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share