Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 9:06 PM
Study NCT ID:
NCT06469112
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2024-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vibration on Pain During Subcutaneous Heparin Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-06-16', 'studyFirstSubmitQcDate': '2024-06-16', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity in mm', 'timeFrame': '6 months', 'description': 'A 10-cm vertical VAS will used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible.'}], 'secondaryOutcomes': [{'measure': 'weight', 'timeFrame': '6 months', 'description': 'weight in kilograms'}, {'measure': 'height', 'timeFrame': '6 months', 'description': 'height in meters'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subcutaneous heparin injection', 'pain', 'non-pharmacological method', 'vibration'], 'conditions': ['Pain', 'Asthma', 'Pulmonary Disease', 'Chest Disorder']}, 'descriptionModule': {'briefSummary': 'Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.\n\nMethods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* being over the age of 18\n* having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment\n* having no coagulation disorder\n* having no disorder which could affect pain perception,\n* having no incision, lipodystrophy or finding of infection at the injection site,\n* having no communication problem, and voluntarily agreeing to participate in the research\n\nExclusion Criteria:\n\n* being under the age of 18\n* having diabetes mellitus\n* peripheral vascular disease, etc. which could affect the perception of pain\n* not being conscious, refusing to participate in the research or opting to leave the study at any point."}, 'identificationModule': {'nctId': 'NCT06469112', 'briefTitle': 'The Effect of Vibration on Pain During Subcutaneous Heparin Injection', 'organization': {'class': 'OTHER', 'fullName': 'Uludag University'}, 'officialTitle': 'The Effect of Vibration on Pain During Subcutaneous Heparin Injection: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2023-28/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Vibration Application Group', 'description': 'With individuals in this group, device will be used to provide vibration. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups. There is a motor in the body which provides vibration. The device also has ice wings behind the body, which are used to provide cold, but these will not used in this research.\n\nThe device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection will performed. For one minute before the injection, a slight non-discomforting vibration will make, and this will be continue while the injection was given. In this study, only the body of the device will be used to provide vibration.', 'interventionNames': ['Device: Vibration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: Intervention Control Group', 'description': 'The device was used with participants in this group. The device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off.', 'interventionNames': ['Other: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Control: Nonintervention Group', 'description': 'No intervention was performed before or during the procedure with the participants in the control group, and the standard subcutaneous heparin injection procedure was carried out.'}], 'interventions': [{'name': 'Vibration', 'type': 'DEVICE', 'description': 'The device was used to provide vibration with the participants in this group. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups.', 'armGroupLabels': ['Experimental: Vibration Application Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The device was used with participants in this group. The device, at room temperature, was placed by the researcher 5cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off.', 'armGroupLabels': ['Placebo: Intervention Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Uludag University Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uludag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Bursa Uludag University, Department of Nursing', 'investigatorFullName': 'Dilek Yilmaz, PhD', 'investigatorAffiliation': 'Uludag University'}}}}