Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT03645369
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075662', 'term': 'Injection Site Reaction'}, {'id': 'D004438', 'term': 'Ecchymosis'}], 'ancestors': [{'id': 'D005119', 'term': 'Extravasation of Diagnostic and Therapeutic Materials'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This study was conducted on receiving treatment patients in the Orthopedics and Traumatology wards of a university hospital.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Measure via VAS', 'timeFrame': 'Immediately after injection', 'description': 'The VAS was used to measure pain intensity. The VAS was composed of a 10-cm long line, which had subjective descriptive expressions on both sides (0 cm: no pain and 10 cm: unbearable pain). The individual was asked to make a sign on the line indicating the degree of the pain. The numerical values were recorded by the researcher.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subcutaneous heparin', 'injection pain', 'ecchymosis'], 'conditions': ['Injection Site Reaction', 'Injection Site Bruising']}, 'referencesModule': {'references': [{'pmid': '26263287', 'type': 'RESULT', 'citation': 'Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105.'}]}, 'descriptionModule': {'briefSummary': 'Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.', 'detailedDescription': 'The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).\n\nAll the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be older than 18 years\n* Open to communication\n* No complications during the operation\n* Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and\n* Platelet count (150.000-300.000)\n* Give consent to participate in the study\n\nExclusion Criteria:\n\n* Oral and parenteral anticoagulant treatment for at least 5 days\n* Infection, scar tissue or incision, and parenteral treatment in their abdominal area\n* Hematological and allergic disease'}, 'identificationModule': {'nctId': 'NCT03645369', 'briefTitle': 'Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Saglik Bilimleri University'}, 'officialTitle': 'The Effectiveness of Mechano-Analgesia and Cold Application', 'orgStudyIdInfo': {'id': '108400987-67'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechano-Analgesia', 'description': 'The first SC heparin injections were applied from the right abdominal region using ShotBlocker®.', 'interventionNames': ['Device: ShotBlocker']}, {'type': 'EXPERIMENTAL', 'label': 'Cold Application', 'description': 'The second SC heparin injections were applied from the left abdominal region with an ice pack', 'interventionNames': ['Device: Ice pack']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The second SC heparin injections were applied from the lower abdominal region without any additional application'}], 'interventions': [{'name': 'ShotBlocker', 'type': 'DEVICE', 'description': 'ShotBlocker is a drug-free tool with no side effects and does not require preparation. It is a flexible, plastic, C-shaped device with a number of short (2 mm) blunt contact points on its back.', 'armGroupLabels': ['Mechano-Analgesia']}, {'name': 'Ice pack', 'type': 'DEVICE', 'description': 'Ice pack containing gel', 'armGroupLabels': ['Cold Application']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Saglik Bilimleri University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Demet İnangil, PhD', 'investigatorAffiliation': 'Istanbul Saglik Bilimleri University'}}}}