Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 8:46 AM
Study NCT ID:
NCT06053450
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2023-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline perceived stress as measured by the Perceived Stress Scale', 'timeFrame': '4 weeks', 'description': 'Scores are measured on 0-4 scale with 0 indicating never and higher scores are more frequent.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Essential Oil Inhalation Patches', 'Essential oil and nursing stress', 'Medical-Surgical unit'], 'conditions': ['Nursing Personnel']}, 'referencesModule': {'references': [{'pmid': '16705307', 'type': 'BACKGROUND', 'citation': 'Spence Laschinger HK, Leiter MP. The impact of nursing work environments on patient safety outcomes: the mediating role of burnout/engagement. J Nurs Adm. 2006 May;36(5):259-67. doi: 10.1097/00005110-200605000-00019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to compare the use of an essential oil inhalation patch in medical surgical nurses on perceived burn-out and stress.\n\nThe main question is can essential oil inhalation patches decrease perceived burn-out and stress.\n\nParticipants will\n\n* Take part in the study over 30 days, alternating weeks, resulting in each participant using six patches over six shifts.\n* Complete anonymous Perceived Stress Survey (PSS) before the study begins and at the conclusion of the study.\n* Participants will also complete a (different) survey after two weeks.', 'detailedDescription': 'Essential Oil inhalation patches are a nonpharmacological option that is worn by the nursing staff on an inpatient medical-surgical unit to determine the efficacy of patch on staff perceived stress \\& burn-out levels. Each participant will wear a new patch during six work shifts. Location is on chest or the ID badge area where it can be easily accessed to. The patch provides up to 8 hours of aromatic support. The patches use a unique patented technology that slows the release of the aromatic molecules while maintaining the purity and vitality of the essential oil. The FDA approved medical adhesive patches are roughly 1x1" in size, and are inhalation only- no contact of essential oils on skin. The patch is portable and discreet. No overwhelming aroma for others. The patch has directions for use on package with an expiration date. Used for a non-specific purpose for stress reduction environment for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full time employee (Nurse, LPN, or LNA) working on L3WD and L4WC\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Pregnant/breastfeeding or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT06053450', 'briefTitle': 'The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.', 'orgStudyIdInfo': {'id': 'STUDY02001908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Essential Oil Ptach', 'description': 'The nursing staff will wear an essential oil patch for 2 weeks.', 'interventionNames': ['Other: Oil Inhalation Patch']}], 'interventions': [{'name': 'Oil Inhalation Patch', 'type': 'OTHER', 'otherNames': ['Quella; Elequil'], 'description': 'Each participant will wear a patch for a work week (3 worked shifts) and then no patch is worn for a week. This alternates for a total of a month.', 'armGroupLabels': ['Essential Oil Ptach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Rachel G. Blier, MSN,RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DHMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Educator', 'investigatorFullName': 'Rachel G. Blier', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}