Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:30 AM
Study NCT ID:
NCT07363668
Status:
COMPLETED
Last Update Posted:
2026-01-23
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity (VAS score)', 'timeFrame': '5, 30, 60, 90, and 120 minutes after the massage session and on postoperative Day 1', 'description': 'Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.'}, {'measure': 'postoperative recovery (postoperative recovery ındex score)', 'timeFrame': 'Baseline (preoperative) and postoperative Day 1', 'description': "Postoperative recovery was assessed using the Postoperative Recovery Index (PRI), a validated questionnaire used to evaluate patients' recovery after surgery. Higher scores indicate better postoperative recovery."}], 'secondaryOutcomes': [{'measure': 'sleep quality (visual sleep scale score)', 'timeFrame': 'Baseline (preoperative) and postoperative Day 1', 'description': 'Sleep quality was assessed using the Visual Sleep Scale (VSS), a self-reported scale used to evaluate perceived sleep quality. Higher scores indicate better sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing', 'Aromatherapy', 'Foot massage', 'Laparoscopic cholecystectomy', 'Sleep quality', 'Postoperative recovery'], 'conditions': ['Cholelithiasis', 'Cholecystitis', 'Gallbladder Diseases', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study aims to evaluate the effects of aromatherapy foot massage on postoperative pain, sleep quality, and recovery in patients undergoing laparoscopic cholecystectomy.', 'detailedDescription': 'This study is a randomized controlled trial conducted in patients undergoing laparoscopic cholecystectomy. Eligible patients are randomly assigned to either an aromatherapy foot massage group or a control group receiving standard postoperative care.\n\nIn the intervention group, aromatherapy foot massage is applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later. The control group receives routine postoperative care without massage.\n\nPain intensity is assessed using the Visual Analog Scale (VAS). Sleep quality is assessed using the Visual Sleep Scale, and postoperative recovery is assessed using the Postoperative Recovery Index. Measurements are performed preoperatively and during the postoperative period according to the study protocol.\n\nThe study is conducted in accordance with ethical principles, and written informed consent is obtained from all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Patients undergoing laparoscopic cholecystectomy\n* Able to communicate and provide informed consent\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* Patients with cognitive impairment or communication difficulties\n* Patients with chronic pain disorders\n* Patients using continuous analgesic or sedative medication\n* Patients with complications requiring intensive care\n* Patients who decline to participate'}, 'identificationModule': {'nctId': 'NCT07363668', 'briefTitle': 'Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '2023/47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatherapy foot massage', 'description': 'Patients receiving aromatherapy foot massage in addition to standard postoperative care', 'interventionNames': ['Other: aromatherapy foot massage']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Patients receiving standard postoperative care without aromatherapy massage'}], 'interventions': [{'name': 'aromatherapy foot massage', 'type': 'OTHER', 'description': 'Aromatherapy foot massage applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later.', 'armGroupLabels': ['Aromatherapy foot massage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Research and Application Center', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From study completion', 'ipdSharing': 'YES', 'description': 'Data will be shared in an anonymized form upon request from researchers.', 'accessCriteria': '•Who can access it: Authorized researchers and academic institutions. • Conditions: • Requesting researchers must obtain ethical committee approval from their institution. • Data will be shared in an anonymized form and for research purposes only. • Requests must be made in writing via PRS.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc', 'investigatorFullName': 'Ümmügülsüm Dursun', 'investigatorAffiliation': 'Ataturk University'}}}}