Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-25 @ 10:51 PM
Study NCT ID:
NCT02764567
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Essential Oil Aromatherapy Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009822', 'term': 'Oils, Volatile'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Scores', 'timeFrame': 'At the time of study enrollment and again upon completion at 6 months'}, {'measure': 'Change in Anxiety Scores', 'timeFrame': 'At the time of study enrollment and again upon completion at 6 months'}], 'secondaryOutcomes': [{'measure': 'Number of venipunctures needed to collect required sample', 'timeFrame': 'At the time of study completion at 6 months'}, {'measure': 'Number of blood collection tubes required for sample', 'timeFrame': 'At the time of study completion at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Phobia Phlebotomy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://healingscents.net/blogs/learn/18685859-history-of-essential-oils', 'label': 'Healing scents. (2015). Retrieved 12/23, 2015'}, {'url': 'http://roberttisserand.com/2011/04/gattefosses-burn/', 'label': "Tissearnd, R. (2011). Gattefossé's burn. Retrieved 12/23, 2015"}]}, 'descriptionModule': {'briefSummary': 'Lab sampling for clinical trial participants can be a stressful and painful experience. Most trial participants will have blood drawn for lab samples at multiple study visits. The participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more than one venipuncture occurs. In addition, the number of collection tubes can increase the anxiety level of the patient and the phlebotomist.\n\nThis project proposes to evaluate if essential oil aromatherapy results in less pain and /or anxiety when compared to usual care.', 'detailedDescription': 'The process of drawing blood for can be painful and stressful for any patient. Those patients who participate in a clinical trial agree to frequent lab sampling to monitor for effect and safety of the investigational product. The frequency is variable, from several times a day for a participant in the hospital to annually for some trials. Participants have reported anxiety regarding the number of tubes to be drawn, even resulting in near syncope, and pain with the venipuncture process.\n\nThe clinical trial nurses at HealthEast have utilized a variety of therapeutic techniques to ease the pain and anxiety experienced by the trial subjects, such as redirection, deep breathing, hand massage and guided imagery. These techniques have not been evaluated for effectiveness in easing pain and anxiety nor have they been compared with no intervention to determine if any intervention was more efficacious in alleviating pain and/or anxiety.\n\nThe primary objective of this study is determine if aromatherapy with an essential oil has a higher reported effect in anxiety and pain relief with venipunctures than standard of care (no therapy) among participants in HealthEast Clinical Trials Office studies.\n\nSecondary objectives include comparing the number of venipunctures and blood collection tubes in the treatment arms.\n\nThis is a randomized, open label, prospective single site study designed to determine the effect of essential oil aromatherapy compared to usual care on pain and anxiety associated with venipunctures for clinical trial participants in the HealthEast Heart Care Clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be at least 18 years of age\n2. Must be currently participating in a clinical trial at HealthEast\n\nExclusion Criteria:\n\n1. Known allergy to any of the oils used for aromatherapy\n2. Less than age 18\n3. Declined to participate'}, 'identificationModule': {'nctId': 'NCT02764567', 'briefTitle': 'Essential Oil Aromatherapy Intervention', 'organization': {'class': 'OTHER', 'fullName': 'HealthEast Care System'}, 'officialTitle': 'Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy', 'orgStudyIdInfo': {'id': 'HE 16 04 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatherapy', 'description': "The participants randomized to aromatherapy will be offered one of three essential oils, 'applied' to their smell zone via cotton ball that are known to have anti-anxiety effect. These are:\n\n* ginger\n* calming\n* lavender The participant's choice will be documented in a database. The participant can chose an oil each time (i.e., they are not bound to use only the first choice oil). Pain and anxiety will be measured prior to receiving the essential oils and again after the phlebotomy procedure. Blood pressure and pulse will also be measured post-phlebotomy.", 'interventionNames': ['Other: Essential Oil']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'The participants randomized to standard of care will proceed to the outpatient phlebotomy room in the Heart Care Clinic as per usual care. Pain, anxiety, blood pressure and pulse will be assessed pre and post-procedure.'}], 'interventions': [{'name': 'Essential Oil', 'type': 'OTHER', 'description': 'Participants in this arm will be offered one of three essential oils: ginger, lavender or calming', 'armGroupLabels': ['Aromatherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55104', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthEast Clinical Trials Office', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Beth Jorgeonson, RN, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthEast Care System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study results will be shared with the organization and submitted for publication. Individual participant data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthEast Care System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}