Chronic PainNCT05910892
Aromatherapy and Pain
A study testing Aromatherapy packet in people with Chronic Pain, run by University of Washington.
Trial summary
Effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Aromatherapy packet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English language speaker
- Age <18
- Allergy to essential oils
- Asthmatic
- Patient unable to self-administer aromatherapy
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Aromatherapy packet, Placebo packet
- Keywords
- Intramuscular Stimulation Therapy, Trigger Point Injections, Aromatherapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy packetDrug
Also called Aromatherapy
5 deep breaths from packet prior to treatment
Placebo packetDrug
Also called Placebo
5 deep breaths from packet prior to treatment
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy before treatment | Active comparator | Subject receives aromatherapy before IMS treatment or trigger point injection Receives: Drug: Aromatherapy packet |
| Placebo before treatment | Placebo comparator | Subject receives placebo before IMS treatment or trigger point injection Receives: Drug: Placebo packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after the Procedure
Secondary outcomes (1)
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).
Measured: Immediately after the Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Contract was never finalized and UW GCA closed the study due to lack of funding and activity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Tick, University of Washington
- Investigators
- Heather Tick, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910892
- Sponsor's protocol ID
- STUDY00007869
- Status last verified
- May 2025
- First submitted
- 29 Apr 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on the Incidence and Severity of Post Procedure Pain and Discomfort in Patients
- ClinicalTrials.gov ID
- NCT05910892
- Acronym / sponsor ID
- STUDY00007869
- Conditions
- Chronic Pain
- Keywords
- Intramuscular Stimulation Therapy, Trigger Point Injections, Aromatherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contract was never finalized and UW GCA closed the study due to lack of funding and activity.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy before treatment | Active comparator | Drug: Aromatherapy packetSubject receives aromatherapy before IMS treatment or trigger point injection |
| Placebo before treatment | Placebo comparator | Drug: Placebo packetSubject receives placebo before IMS treatment or trigger point injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Non-English language speaker
- Age <18
- Allergy to essential oils
- Asthmatic
- Patient unable to self-administer aromatherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy packetAlso: Aromatherapy5 deep breaths from packet prior to treatment | Drug | Aromatherapy before treatment |
| Placebo packetAlso: Placebo5 deep breaths from packet prior to treatment | Drug | Placebo before treatment |
Primary outcome
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).
1 secondary outcome
Change in Overall Experience
Time frame: Immediately after the Procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Tick, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy packet in people with Chronic Pain, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acute Pain (time frame: Immediately after the Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.