Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-31 @ 8:17 AM
Study NCT ID:
NCT06769503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2025-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aromatherapy on Anxiety in Relatives of Emergency Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'It will be conducted as a randomized controlled experimental study in a pre-test-post-test control group experimental model.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-05', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety level', 'timeFrame': 'It will take approximately 30 minutes.', 'description': 'The anxiety levels of patients will be measured using the "State and Trait Anxiety Scale".\n\nState and Trait Anxiety Scale; consists of two scales. Each scale has 20 questions. Scoring is between 1-4. Each scale score varies between 20-80 points. A high scale score indicates high anxiety. A low scale score indicates low anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emergency department', 'aromatherapy', 'anxiety'], 'conditions': ['Emergency Service, Hospital', 'Aromatherapy', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effect of aromatherapy (lavender oil) application on the anxiety level of relatives of patients admitted to the emergency department.\n\nThe hypotheses of the study are as follows:\n\nH1: Aromatherapy (lavender oil) application has an effect on the anxiety level of relatives of patients presenting to the emergency department.\n\nH0: Aromatherapy (lavender oil) application has no effect on the anxiety level of relatives of patients presenting to the emergency department.', 'detailedDescription': 'In the experimental group; After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. The participants will be made to smell lavender oil dropped on gauze by the researchers for an average of 3-5 minutes. After the intervention, the state and trait anxiety scales will be applied as a post-test approximately 15 minutes later.\n\nIn the control group; After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patients who agree to participate in the study. No intervention will be made to the participants in the control group. After a certain waiting period (after an average of 15 minutes), the state and trait anxiety scales will be applied as a post-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Being 18 years of age or older\n2. Not having a problem with smell\n3. Accompanying the patient\n4. Not having a psychiatric problem\n\nExclusion Criteria:\n\n1. Refusing to participate in the study or wanting to leave\n2. Having an upper respiratory tract infection\n3. Known history of allergy (lavender oil)\n4. Having a chronic respiratory disease'}, 'identificationModule': {'nctId': 'NCT06769503', 'briefTitle': 'Effect of Aromatherapy on Anxiety in Relatives of Emergency Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Bitlis Eren University'}, 'officialTitle': 'Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University', 'orgStudyIdInfo': {'id': 'Okutan2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Intervention Group After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patient who agree to participate in the study. The participants will be made to smell lavender oil dropped on gauze by the researchers for an average of 3-5 minutes. The state and trait anxiety scales will be applied as a post-test approximately 15 minutes after the intervention.', 'interventionNames': ['Other: aromatherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control Group After the patient is registered in the emergency department, the participant introduction form and state-trait anxiety scales will be applied as a pre-test to the relatives of the patient who agree to participate in the study. No intervention will be made to the control group participants. After a certain waiting period (average of 15 minutes), the state and trait anxiety scales will be applied as a post-test.'}], 'interventions': [{'name': 'aromatherapy', 'type': 'OTHER', 'description': 'Lavender oil dropped on gauze will be smelled for approximately 3-5 minutes.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Bitlis', 'country': 'Turkey (Türkiye)', 'facility': 'Bitlis Eren University', 'geoPoint': {'lat': 38.40115, 'lon': 42.10784}}], 'centralContacts': [{'name': 'Şerafettin OKUTAN, Dr.', 'role': 'CONTACT', 'email': 'serafettin.okutan@gmail.com', 'phone': '+90 (434) 222 01 01', 'phoneExt': '8325'}], 'overallOfficials': [{'name': 'Şerafettin OKUTAN, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bitlis Eren University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitlis Eren University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Serafettin Okutan', 'investigatorAffiliation': 'Bitlis Eren University'}}}}