Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT06380933
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Richards-Campbell Sleep Questionnaire', 'timeFrame': 'day 1 and implementation of interventions', 'description': '0-100mm'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating of Comfort', 'timeFrame': 'day1and implementation of interventions', 'description': '0-10 points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respirator-dependent patient', 'warm water foot baths', 'lavender essential oil', 'sleep quality', 'comfort level', 'heartbeat', 'blood pressure'], 'conditions': ['Sleep Quality', 'Comfort']}, 'referencesModule': {'references': [{'pmid': '33112004', 'type': 'BACKGROUND', 'citation': 'Aghamohammadi V, Salmani R, Ivanbagha R, Effati Daryani F, Nasiri K. Footbath as a safe, simple, and non-pharmacological method to improve sleep quality of menopausal women. Res Nurs Health. 2020 Dec;43(6):621-628. doi: 10.1002/nur.22082. Epub 2020 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath.', 'detailedDescription': "Methods: This study is a randomized clinical trial. It adopts a two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days. The measurement tools used self-made structured questionnaires, the Richards-Campbell Sleep Questionnaire （RCSQ）, Numerical Rating of Comfort （NRC）, and heartbeat and blood pressure monitors. Data analysis included descriptive statistics, Chi-square and Fisher's exact correction tests, unpaired t tests and repeated measures ANOVA inferential statistical analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been using a ventilator for 21 days or more\n* Individuals aged 45 years or older\n* Clear consciousness and the ability to compare hands or hold a pen, with proficiency in Mandarin or Taiwanese communication\n* Willingness to participate in the study after receiving an explanation of the research purpose\n\nExclusion Criteria:\n\n* Individuals with severe mental illness\n* Those with cognitive impairments\n* Severe visual or hearing impairments\n* History of lower limb venous thrombosis\n* Amputation or inflammation in the lower limbs\n* Muscle contractures in the lower limbs\n* Peripheral neuropathy\n* Allergic history related to essential oils'}, 'identificationModule': {'nctId': 'NCT06380933', 'briefTitle': 'The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort', 'organization': {'class': 'OTHER', 'fullName': 'Dalin Tzu Chi General Hospital'}, 'officialTitle': 'The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort Among Ventilator-Dependent Patients', 'orgStudyIdInfo': {'id': 'B11103008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'foot bath with lavender essential oil for 3 days, and then received routine care for 3 days', 'interventionNames': ['Other: experimental group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'first received routine care for 3 days, and then received lavender essential oil with foot bath for 3 days'}], 'interventions': [{'name': 'experimental group', 'type': 'OTHER', 'description': 'first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Hsu Mei-Lian', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'overallOfficials': [{'name': 'Hsu M L, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tzu Chi Medical Foundation Dalin Tzu Chi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalin Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}