Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-08 @ 12:05 PM
Study NCT ID:
NCT06853860
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hand Massage Applied With Two Different Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be divided into experimental and control groups. Patients will know that they are participating in the study and the interventions that will be applied to them, but they will be blinded by not knowing which group they are in. The study data will be collected by a second researcher who is blinded to the groups. In the statistical analysis of the data, the groups will be labeled as group 1 and group 2, and the third researcher will be blinded when evaluating the results. Thus, the third researcher will be blinded to the study groups. In order to avoid bias in the evaluation of the results, the first researcher who is not blinded will not participate in any stage of the evaluation process.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a double-blind randomized controlled trial planned to investigate the effects of hand massage applied with two different methods on pain, anxiety and physiological parameters in patients undergoing coronary angiography.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Pain Score on Visual Analog Scale (VAS)', 'timeFrame': '0 hour (baseline), 1st hour, 2nd hour, 3rd hour', 'description': 'Pain will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Higher scores indicate more severe pain.'}, {'measure': 'State Anxiety Scale Mean Score', 'timeFrame': '0 hour (baseline), 1st hour, 2nd hour, 3rd hour', 'description': 'Anxiety will be measured using the State Anxiety Scale, a validated questionnaire assessing current anxiety levels. Higher scores indicate higher levels of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Angiopathy, Peripheral', 'Pain, Acute', 'Reflexology']}, 'descriptionModule': {'briefSummary': 'There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography. Therefore, the aim of this study is to examine the effects of reflexology hand massage and classical hand massage on pain, anxiety and physiological parameters after coronary angiography.', 'detailedDescription': 'There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients who are over 18 years old\n\n * Can speak Turkish\n * Agree to participate in the study\n * Have not undergone emergency coronary angiography\n * Have not consumed coffee or hypnotic drugs at least 12 hours before\n * Have no history of chronic pain (e.g. arthritis)\n * Are not addicted to alcohol or drugs\n * Have no psychological problems (such as depression, anxiety disorder)\n * Have no problem with having their hands massaged; those who do not have any skin lesions, sensory and motor disorders, amputations, burns, or pathological diseases related to muscles and bones\n * Have not used anxiolytics\n\nExclusion Criteria:\n\n* • Those who do not volunteer to participate in the study\n\n * Those who have any skin lesions, burns, open wounds, muscle and bone pathological diseases on their hands,\n * Those who develop delirium during the follow-up period\n * Those who develop complications after coronary angiography (such as bleeding, etc.)\n * Arrhythmia\n * Hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT06853860', 'briefTitle': 'Effects of Hand Massage Applied With Two Different Methods', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Comparison of the Effects of Reflexology and Classical Hand Massage on Pain, Anxiety, and Vital Signs in Patients After Coronary Angiography', 'orgStudyIdInfo': {'id': 'KutahyaHSU-NECİBE-DAĞCAN-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'reflexology group', 'description': 'reflexology group', 'interventionNames': ['Other: reflexology massage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Classic hand massage group', 'description': 'Classic hand massage group', 'interventionNames': ['Other: classic hand massage']}], 'interventions': [{'name': 'reflexology massage', 'type': 'OTHER', 'description': 'classic hand massage', 'armGroupLabels': ['reflexology group']}, {'name': 'classic hand massage', 'type': 'OTHER', 'description': 'classic hand massage', 'armGroupLabels': ['Classic hand massage group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Kütahya', 'country': 'Turkey (Türkiye)', 'facility': 'Necibe', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'overallOfficials': [{'name': 'Burcu NAL, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kütahya Health Sciences University, Faculty of Health Sciences'}, {'name': 'Mehmet Ali ASTARCIOĞLU, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kütahya Health Sciences University, Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Nursing', 'investigatorFullName': 'Necibe Dağcan', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}