Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 4:51 AM
Study NCT ID:
NCT06381804
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shotblocker and Palm Stimulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS) pain Scale score', 'timeFrame': 'up to 6 weeks', 'description': 'The Visual analog scale (VAS) score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.', 'detailedDescription': 'It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the research,\n\n * Those who will receive vitamin B injection ordered by physician due to B12 deficiency,\n * Conscious and oriented,\n * Able to understand and speak Turkish,\n * Age range is between 18-65,\n * Having no vision or hearing problems,\n * Pain score of 2 or less when evaluated with a visual analog scale,\n * Able to lie in the right lateral position where injection can be administered,\n * Those who have not had an IM injection into the right ventrogluteal area in the last week,\n * Body mass index is within the normal range (25.0-29.9 kg/m2) according to WHO,\n * Those who have not used any analgesics or muscle relaxants in the last 24 hours,\n * Does not have any problems such as hardness, mass, edema or infection in the area to be injected,\n * According to his own statement, he has no psychiatric diagnosis,\n\nExclusion Criteria:\n\n* Having pain anywhere in the body,\n\n * Narcotic type or different analgesic area before application,\n * Pregnant or suspected of pregnancy,\n * Individuals in menstrual period,\n * Receiving chemotherapy and radiotherapy treatment,\n * Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,\n * Those who have disabilities in grasping their hands,'}, 'identificationModule': {'nctId': 'NCT06381804', 'briefTitle': 'Effect of Shotblocker and Palm Stimulator', 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': 'Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '24YL9001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'shotblocker', 'description': 'shotblocker', 'interventionNames': ['Other: shotblocker']}, {'type': 'EXPERIMENTAL', 'label': 'palm stimulator', 'description': 'palm stimulator', 'interventionNames': ['Other: palm stimulator']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'control'}], 'interventions': [{'name': 'shotblocker', 'type': 'OTHER', 'description': 'shotblocker device', 'armGroupLabels': ['shotblocker']}, {'name': 'palm stimulator', 'type': 'OTHER', 'description': 'palm stimulator', 'armGroupLabels': ['palm stimulator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Meram', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.82985, 'lon': 32.46777}}], 'overallOfficials': [{'name': 'Gülden Basit, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Necmettin Erbakan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Gulden Basit', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}