Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:29 AM
Study NCT ID:
NCT07305493
Status:
COMPLETED
Last Update Posted:
2026-01-02
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Treatment for Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participant will not get any information of what substances that will be the exposure or what group they are added in Care provider will received bottle A and B without any explanation what substances inside the bottle. Then the care provider will set the diffuser and diffused the substances for 30 minutes to participants'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be plotted into two groups, consist of experimental group and controls group, participation allocation will be randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-27', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Score', 'timeFrame': 'Before exposure and 15 minutes after exposure has done', 'description': 'This parameter measured using State Trait Anxiety Inventory (STAI) Questionnaire. This questionnaire can be used to assess state and trait anxiety. It is consist of 2 segment, state segment for current anxiety scale and trait segment for any consistent anxiety feeling scale. This questionnaire have score range between 20 (minimum) and 80 (maximum). It is classified as mild anxiety for 20-39 points, moderate anxiety for 40-59 points, and severe anxiety for 60-80 points. This questionnaire has been tested for its validity by McDowell in 2006 with interval value 0,88. For its reliability, it has been tested by McDowell too in 2006 with alpha for S part 0,93 and T part 0,91'}], 'secondaryOutcomes': [{'measure': 'Pain Scale', 'timeFrame': 'Before exposure and 15 minutes after exposure has done', 'description': 'This parameter measured with NRS questionnaire for assessing pre-post exposure pain scale changes. This questionnaire will have score range between 0-10 points. 0 point stands for no pain, 1-3 points will stands for mild pain, 4-6 for moderate pain, and 7-10 stands for severe pain'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aromatherapy', 'Lavandula', 'Anxiety', 'Anxiety Disorder', 'Pain', 'Mind-Body Therapies'], 'conditions': ['Anxiety', 'Pain', 'Aromatherapy']}, 'descriptionModule': {'briefSummary': 'This clinical trial will assess whether aromatherapy inhalation (especially lavender extract essential oil) can be used as a complementary therapy for anxiety and pain. In this study, outcomes will be measured using the Numeric Rating Scale (NRS) for pain score and State-Trait Anxiety Inventory (STAI) questionnaire to assess state and trait anxiety scores. The two questionnaires above will be used to determine pre-post pain and anxiety scores after exposure. This study\'s primary research question is "Does linalool in lavender extract essential oil aromatherapy reduce anxiety in patients with pain complaints ?". With the question above, it is hypothesized that linalool can be an anti-anxiety towards pain. The product of aromatherapy will be tested in a GC-MS assay for every substance inside and proving linalool as a key substance. To prove the effect of linalool, this study will compare diffused lavender extract essential oil aromatherapy with a placebo to determine its effect as an anxiety reliever.', 'detailedDescription': 'The objective in this clinical trial is to evaluate the effect of linalool in lavender extract essential oil aromatherapy as anti-anxiety treatment for pain. The linalool inside lavender extract will be proven with GC-MS assay first. Then, after linalool has been confirmed as a key substance inside the extract, the lavender extract essential oil will be mixed with water to dilute it before it is exposed to participants in the experimental group. This study will assess anxiety and pain scale using the Numeric Rating Scale (NRS) for pain score and the State-Trait Anxiety Inventory (STAI) before exposure and 15 minutes after the exposure has been done. This complementary therapy can be an innovation in addition to conventional pain therapy, with the theory that anxiety towards pain can amplify the pain, and GABA-ergic activity in the brain can help inhibit the pain.\n\nStudy design: This study is using a Randomized Controlled Trials (RCT) with pre and post test assessment. This study will be blinding the participants and care provider.\n\nAllocation:\n\n* Participant will be allocated using simple randomization to the experimental or placebo group\n* All the participants who agreed to the informed consent will be included and randomized to the experimental or placebo group\n* Then every participant will be exposed to the intervention as scheduled personally\n\nGroup/Arm:\n\n* Experimental Group (Lavender Aromatherapy group)\n* Placebo Control Group\n\nIntervention:\n\n* The experimental group will use Young Living Lavender Extract Essential Oil to be diffused and exposed to participants as inhalation therapy in the experimental group. It consists 2 mL of lavender essential oil diluted in 40 mL of water (H2O). It will be exposed to participants for 30 minutes\n* Placebo / Control group will be exposed to diffused water (H2O) for 30 minutes\n\nData Analysis Plan: The data will be analyzed using univariate analysis and bivariate analysis (Independent T-Test, Paired T-Test, Wilcoxon Test, ANOVA, and/or Mann-Whitney test)\n\nAnticipated outcome:\n\n* Reduction in anxiety score\n* Reduction in pain score\n* Low risk of allergies\n* No adverse event\n\nRisks:\n\n* Allergies\n* Adverse event\n\nBenefits:\n\n* Innovation in addition to pain conventional therapy as a complementary therapy\n* Widely accessible\n* Prices vary\n* Enhances treatment and prevents reduced function or reduced quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient that complains about pain (acute or chronic) that do not have any allergic history of lavender\n* Patient doesnt have any abnormalities / disease in olfactory/respiratory\n* Pain are classified as moderate to severe pain (higher than 4 points in NRS)\n* Patient is not in pregnant conditions\n\nExclusion Criteria:\n\n* Exposure are not completed for 30 minutes due to any cause\n* Consuming any pain relieving drug (such as NSAID) 1 hour before exposure or in the middle between pre and post-test period\n* Any adverse event that associated to exposure or did not associated to exposure\n* There is or appears to be an allergy to lavender aromatherapy ingredients.'}, 'identificationModule': {'nctId': 'NCT07305493', 'briefTitle': 'Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Treatment for Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Islam Indonesia'}, 'officialTitle': 'The Use of Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Toward Pain', 'orgStudyIdInfo': {'id': '9/Ka.Kom.Et/70/KE/I/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lavender Aromatherapy Group', 'description': 'This group will be consist of 34 participants that already randomized. This group will be exposed to lavender aromatherapy', 'interventionNames': ['Combination Product: Lavender Extract Aromatherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'This control will be exposed to water diffused gas as a control to experimental group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lavender Extract Aromatherapy', 'type': 'COMBINATION_PRODUCT', 'description': 'This group will be exposed to diffused Lavender Extract Essential Oil Aromatherapy. Aromatherapy given to this group will be linalool concentrate (verificated with GC-MS of the essential oil) in forms of 2 mL Lavender Essential Oil from Young Living diluted in 40 mL water for 30 minutes', 'armGroupLabels': ['Lavender Aromatherapy Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'This intervention will be just an exposure of diffused water (H2O) for 30 minutes as a control to experimental group', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55244', 'city': 'Yogyakarta', 'state': 'D.I.Yogyakarta', 'country': 'Indonesia', 'facility': 'Ludira Husada Hospital', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}], 'overallOfficials': [{'name': 'Angga A Derryawan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Islam Indonesia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Supporting information will be available until end of December 2027 (4 years after the study has completed)', 'ipdSharing': 'YES', 'description': 'Individual participant data that will be shared will be raw data of anxiety and pain score. If requested, participant demographic data will be shared in limited information due to privacy', 'accessCriteria': 'Anyone who studying / researching and needed raw data can contact this study principal investigator to access this study raw data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Islam Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Angga Ardhan Derryawan, MD', 'investigatorAffiliation': 'Universitas Islam Indonesia'}}}}