Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-01-04 @ 4:31 PM
Study NCT ID:
NCT07237061
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019341', 'term': 'Aromatherapy'}, {'id': 'C045718', 'term': 'lavender oil'}, {'id': 'C052901', 'term': 'lemongrass oil'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in VAS scores for preoperative anxiety', 'timeFrame': '30-60 minutes', 'description': 'preoperative anxiety was ranked by the patient on a scale of 0-100 on a visual acuity scale (VAS) measuring 100mm, in the preoperative ambulatory ward, before and after the intervention/placebo was applied for at least 30 minutes. The change in the VAS score at these 2 timepoints was the primary outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['randomized controlled trial', 'placebo controlled', 'double blinded', 'two arm'], 'conditions': ['Cataract', 'Surgery', 'Vitrectomy', 'Aromatherapy', 'Preoperative Anxiety']}, 'descriptionModule': {'briefSummary': 'This study looks at whether aromatherapy (scent chosen by the patient), is better than routine care, at reducing preoperative anxiety before eye surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mental capacity for informed consent\n* undergoing elective ambulatory eye surgery (including Phacoemulsification, Femtosecond laser-assisted cataract surgery (FLACS), Extracapsular cataract extraction (ECCE) and vitrectomy).\n* surgery only under Monitored Anaesthesia Care (MAC)3\n* surgical duration less than 45 minutes\n\nExclusion Criteria:\n\n* anosmia\n* allergy to aromatherapy oil\n* asthma\n* allergic rhinitis\n* psychiatric disease\n* altered mental state\n* lack of mental capacity\n* active infection\n* pregnancy\n* patient or surgeon refused participation'}, 'identificationModule': {'nctId': 'NCT07237061', 'acronym': 'RELAAC', 'briefTitle': 'Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery - The RELAAC Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2020/01202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': "Patients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch without any aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU).", 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': "Patients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch with 1 drop of their chosen aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU).", 'interventionNames': ['Other: Aromatherapy']}], 'interventions': [{'name': 'Aromatherapy', 'type': 'OTHER', 'otherNames': ['lavender', 'geranium', 'lemongrass', 'sandalwood'], 'description': 'patients chose their preferred aromatherapy scent to be used for at least 30 minutes', 'armGroupLabels': ['intervention']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'odorless dry absorbent adhesive patch', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'local Patient Data Protection Act'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}