Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:01 AM
Study NCT ID:
NCT07373132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly allocated to receive either standardized aromatherapy (lavender essential oil) or placebo (odorless fractionated coconut oil) for five consecutive nights'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Athens Insomnia Scale', 'timeFrame': 'Evaluated at baseline, day 6 and 2-week follow-up.', 'description': 'Total score 0-24; higher scores indicate worse insomnia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of standardized aromatherapy compared with placebo in improving sleep quality among hospitalized elderly female patients with insomnia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, aged ≥60 years.\n* Hospitalized in the Second Affiliated Hospital of Anhui Medical University.\n* Athens Insomnia Scale (AIS) \\>6.\n* Ability to communicate and understand instructions.\n* Non-allergic to essential oils.\n* Fully informed and voluntarily consent to participate.\n\nExclusion Criteria:\n\n* Cognitive impairment-.\n* History of hypersensitivity to aromatherapy oils.\n* Use of sedative-hypnotic medications within past 2 weeks.\n* Sleep disorders secondary to organic or psychiatric diseases.\n* Unable to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT07373132', 'briefTitle': 'Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Anhui Medical University'}, 'officialTitle': 'Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia: Protocol for A Randomized, Double-Blind, Placebo-Controlled Parallel Trial', 'orgStudyIdInfo': {'id': 'ZWei'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aromatherapy', 'interventionNames': ['Other: Aromatherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Aromatherapy', 'type': 'OTHER', 'description': "Verify patient identity and explain the intervention. Ensure comfortable supine or semi-recumbent position. Drop 2 drops of lavender essential oil onto a sterile cotton ball; place inside disposable urine cup.\n\nPosition cup 20 cm from patient's nostrils; instruct patient to perform 10 deep breaths.\n\nPlace cup at bedside until morning. Lay treatment cloth under patient's wrists. Apply 1 drop of lavender oil to both thumbs, perform bilateral Shenmen (HT7) acupoint pressure on the wrist Shenmen acupoint pressure for 10 minutes per side, moderate pressure causing mild local distension but no pain.\n\nRestore patient to comfortable position; remove materials; wash hands. Record any immediate reactions or discomfort.", 'armGroupLabels': ['aromatherapy']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Identical procedure using odorless fractionated coconut oil. Sham acupoint pressure on a non-acupoint location near the wrist performed identically to maintain blinding.', 'armGroupLabels': ['placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zengzeng Wei', 'investigatorAffiliation': 'The Second Hospital of Anhui Medical University'}}}}