Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-21 @ 4:37 PM
Study NCT ID:
NCT06271759
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Effects of a Set of Essential Oils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Affective states - relaxation', 'timeFrame': 'Up to three months', 'description': 'Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100.'}, {'measure': 'Affective states - contentment', 'timeFrame': 'Up to three months', 'description': 'Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100.'}, {'measure': 'Affective states - happiness', 'timeFrame': 'Up to three months', 'description': 'Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100.'}, {'measure': 'Affective states - stress', 'timeFrame': 'Up to three months', 'description': 'Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100.'}, {'measure': 'Affective states - motivation', 'timeFrame': 'Up to three months', 'description': 'Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100.'}, {'measure': 'Affective states - tension', 'timeFrame': 'Up to three months', 'description': 'Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100.'}, {'measure': 'Emotional changes', 'timeFrame': 'Up to three months', 'description': 'Changes in emotional patterns are assessed based on their intensity, one of the three components of emotional reactivity from the Multidimensional Emotion Questionnaire (MEQ). The questionnaire represents a reliable general measure of emotional experience, focusing on 10 discrete emotions (5 positive and 5 negative). Intensity is rated on a 5-Likert scale that ranges from 1 - Very low to 5 - Very high.'}], 'secondaryOutcomes': [{'measure': 'General mental health - Depression', 'timeFrame': 'Up to three months', 'description': 'Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).'}, {'measure': 'General mental health - Anxiety', 'timeFrame': 'Up to three months', 'description': 'Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).'}, {'measure': 'General mental health - Stress', 'timeFrame': 'Up to three months', 'description': 'Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fragrances', 'Essential Oils', 'Well-being', 'Psychological effects', 'Anxiety', 'Stress', 'Depression'], 'conditions': ['Stress', 'Anxiety', 'Well-Being, Psychological', 'Mood']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.\n\nParticipants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart.', 'detailedDescription': 'The potential beneficial effects of a set of Essential Oils (EO) are being tested in the form of a Randomized Clinical Trial (RCT). There are five conditions: a control (receiving a neutral/no-odor stimulus) and four active groups (receiving one of the four EO).\n\nThe study is a within-subjects/between-subjects design with five arms and involves comparisons between pre-intervention and post-intervention between: (a) Initial psychological states of the participants, and (b) After inhalation of the stimuli. Participants will be randomly allocated to one of the five experimental arms.\n\nFor medium effect sizes assumed (f = 0.25), 5 groups and two measurements in time (pre and post stimulus administration) a minimum of 80 subjects total sample size is needed.\n\nAffective states (relaxation, contentment, happiness, motivation, tension), as well as data on mood; depression, anxiety, and stress will be assessed.\n\nData about familiarity, pleasantness and intensity of the stimuli will also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (at least 18 years old)\n\nExclusion Criteria:\n\n* Allergies to Essential Oils\n* Medical conditions that could have an effect on sense of smell'}, 'identificationModule': {'nctId': 'NCT06271759', 'acronym': 'PSYFRAG', 'briefTitle': 'Psychological Effects of a Set of Essential Oils', 'organization': {'class': 'OTHER', 'fullName': 'University of Bucharest'}, 'officialTitle': 'Psychological Effects of a Set of Essential Oils - A Randomized Interventional Trial', 'orgStudyIdInfo': {'id': 'PSYFRAG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fragrance 1 Group', 'description': 'At-home administration of one of the four active stimuli (fragrances), according to the following protocol:\n\n1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being.\n2. Participants will inhale the fragranced stimulus for approximately 10 minutes.\n3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes.\n4. Participants will complete a series of psychological scales (post-measurements).\n5. Participants will repeat this protocol one week apart.', 'interventionNames': ['Other: Fragrance inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Fragrance 2 Group', 'description': 'At-home administration of one of the four active stimuli (fragrances), according to the following protocol:\n\n1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being.\n2. Participants will inhale the fragranced stimulus for approximately 10 minutes.\n3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes.\n4. Participants will complete a series of psychological scales (post-measurements).\n5. Participants will repeat this protocol one week apart.', 'interventionNames': ['Other: Fragrance inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Fragrance 3 Group', 'description': 'At-home administration of one of the four active stimuli (fragrances), according to the following protocol:\n\n1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being.\n2. Participants will inhale the fragranced stimulus for approximately 10 minutes.\n3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes.\n4. Participants will complete a series of psychological scales (post-measurements).\n5. Participants will repeat this protocol one week apart.', 'interventionNames': ['Other: Fragrance inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Fragrance 4 Group', 'description': 'At-home administration of one of the four active stimuli (fragrances), according to the following protocol:\n\n1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being.\n2. Participants will inhale the fragranced stimulus for approximately 10 minutes.\n3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes.\n4. Participants will complete a series of psychological scales (post-measurements).\n5. Participants will repeat this protocol one week apart.', 'interventionNames': ['Other: Fragrance inhalation']}, {'type': 'NO_INTERVENTION', 'label': 'No Fragrance Group', 'description': 'At-home administration of the neutral/no-odor stimulus, according to the following protocol:\n\n1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being.\n2. Participants will inhale the non-fragranced stimulus for approximately 10 minutes.\n3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes.\n4. Participants will complete a series of psychological scales (post-measurements).\n5. Participants will repeat this protocol one week apart.'}], 'interventions': [{'name': 'Fragrance inhalation', 'type': 'OTHER', 'description': 'Inhalation of fragranced essential oils', 'armGroupLabels': ['Fragrance 1 Group', 'Fragrance 2 Group', 'Fragrance 3 Group', 'Fragrance 4 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050663', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cezar Giosan, PhD', 'role': 'CONTACT', 'email': 'giosan@outlook.com', 'phone': '+40730908050'}], 'facility': 'University of Bucharest', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'centralContacts': [{'name': 'Cezar Giosan, PhD', 'role': 'CONTACT', 'email': 'giosan@outlook.com', 'phone': '+40730908050'}], 'overallOfficials': [{'name': 'Cezar Giosan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bucharest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bucharest', 'class': 'OTHER'}, 'collaborators': [{'name': 'IFF (International Flavors & Fragrances)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychology', 'investigatorFullName': 'Cezar Giosan', 'investigatorAffiliation': 'University of Bucharest'}}}}