Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-31 @ 4:17 AM
Study NCT ID:
NCT05910892
Status:
WITHDRAWN
Last Update Posted:
2025-06-22
First Post:
2023-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatherapy and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019341', 'term': 'Aromatherapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008517', 'term': 'Phytotherapy'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Contract was never finalized and UW GCA closed the study due to lack of funding and activity.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2023-04-29', 'studyFirstSubmitQcDate': '2023-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Acute Pain', 'timeFrame': 'Immediately after the Procedure', '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Overall Experience', 'timeFrame': 'Immediately after the Procedure', '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).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intramuscular Stimulation Therapy', 'Trigger Point Injections', 'Aromatherapy'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have received at least one (1) prior IMS or trigger point injection treatment with researcher\n* 18 years of age or older\n* English language speaker\n* has completed Pain Tracker (clinic standard of care) questionnaire prior to study visit\n* any analgesic medication taken must be consistent for both sessions\n\nExclusion Criteria:\n\n* Non-English language speaker\n* Age \\<18\n* Allergy to essential oils\n* Asthmatic\n* Patient unable to self-administer aromatherapy'}, 'identificationModule': {'nctId': 'NCT05910892', 'briefTitle': 'Aromatherapy and Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'The Effect of Aromatherapy on the Incidence and Severity of Post Procedure Pain and Discomfort in Patients', 'orgStudyIdInfo': {'id': 'STUDY00007869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aromatherapy before treatment', 'description': 'Subject receives aromatherapy before IMS treatment or trigger point injection', 'interventionNames': ['Drug: Aromatherapy packet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo before treatment', 'description': 'Subject receives placebo before IMS treatment or trigger point injection', 'interventionNames': ['Drug: Placebo packet']}], 'interventions': [{'name': 'Aromatherapy packet', 'type': 'DRUG', 'otherNames': ['Aromatherapy'], 'description': '5 deep breaths from packet prior to treatment', 'armGroupLabels': ['Aromatherapy before treatment']}, {'name': 'Placebo packet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '5 deep breaths from packet prior to treatment', 'armGroupLabels': ['Placebo before treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Heather Tick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor: School of Medicine', 'investigatorFullName': 'Heather Tick', 'investigatorAffiliation': 'University of Washington'}}}}