Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 8:00 AM
Study NCT ID:
NCT05701904
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vibration and Shotblocker Use in Pregnant Women While Giving Tetanus + Diphtheria Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a control group and 2 intervention groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '4 months', 'description': 'The VAS is a 100 mm straight horizontal line with numbers from 0 to 10 representing the patient\'s initial pain-free and finally the most severe pain they can feel. \'0\' means no pain, \'10\' means severe pain. Participants are asked to mark any number between "0" and "10".'}], 'secondaryOutcomes': [{'measure': 'Visual Patient Satisfaction Scale', 'timeFrame': '4 months', 'description': 'Visual patient satisfaction scale (visual analog patient satisfaction scale) overlaps with the features of the Visual Analog Scale. It indicates the degree of satisfaction out of 10. On one side of the scale, "0" (Not at all satisfied) and "10" (Very satisfied) are on the other side.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing care', 'Management, Pain', 'Patient Satisfaction', 'Intramuscular Injections'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '22588748', 'type': 'RESULT', 'citation': 'Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.'}, {'pmid': '33590594', 'type': 'RESULT', 'citation': 'Dincer B, Yildirim D. The effect of vibration stimulation on intramuscular injection pain and patient satisfaction: Single-blind, randomised controlled study. J Clin Nurs. 2021 Jun;30(11-12):1615-1622. doi: 10.1111/jocn.15715. Epub 2021 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Tetanus-diphtheria vaccine administered to pregnant women may cause pain during and after administration. Due to the pain that may occur, the compliance of pregnant women towards the vaccine may be impaired. Therefore, there is a need for methods that are safe for pregnant women to reduce pain. One of the applications used to reduce pain during intramuscular injection is local mechanical vibration application. With the application of vibration, the tactile receptors are stimulated and the pain is localized in a more limited area. One of the methods used to reduce the pain felt during intramuscular injection is the application of shotblocker applied to the injection site. The protrusions on the Shotbloker temporarily suppress the pain thanks to the pressure it exerts on the skin. Thus, the gates to the central nervous system are closed and pain is reduced. Mechanical vibration and shotblocker procedures applied before injection are non-invasive. Being simple and safe, it is one of the appropriate methods that can be preferred by pregnant women to reduce injection pain. Therefore, in our study, it is aimed to examine the effect of local mechanical vibration and shotblocker application on pain and patient satisfaction before tetenosis-diphtheria vaccine in pregnant women.', 'detailedDescription': 'Pregnant women who meet the inclusion criteria of the study, who request tetanus-diphtheria (0.5 ml) by their family physician, and who agree to participate in the study will be informed about the study and their written and verbal consents will be obtained. Then the vaccine will be administered. Tetanus-diphtheria vaccine will be administered to all pregnant women in the study by IM in the deltoid muscle in the arm they do not use dominantly.\n\nData Collection Tools Individual Introduction Form It was prepared by the researchers by scanning the literature . In the introductory form, there are questions about the age, education level, marital status, occupation, income status, smoking status, gestational week, tetonosis vaccination status, height-weight of the pregnant women.\n\nVisual Analog Scale (VAS) VAS patients are initially painless and eventually represent the most severe pain they can feel.\n\nIt is a 100 mm straight horizontal line with numbers 0 to 10. \'0\' means no pain, \'10\' means severe pain. Participants are asked to mark any number between "0" and "10".\n\nVisual Patient Satisfaction Scale Visual patient satisfaction scale (visual analogue patient satisfaction scale) overlaps with the features of VAS. It indicates the degree of satisfaction out of 10. On one side of the scale, "0" (Not at all satisfied) and on the other side "10" (Very satisfied).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women with tetanus + diphtheria vaccination order', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who volunteered to participate in the study and received written consent\n* Pregnant women who were prescribed tetanus + diphtheria vaccine\n* No acute cause of pain other than injection pain\n* Able to communicate verbally\n* Pregnant women over the age of 18\n\nExclusion Criteria:\n\n* Not willing to participate in the study\n* Pregnant women who are not prescribed tetanus + diphtheria vaccine\n* An acute cause of pain other than injection pain\n* Unable to communicate verbally\n* Pregnant women under the age of 18\n* Those over the age of 18 who are not pregnant'}, 'identificationModule': {'nctId': 'NCT05701904', 'briefTitle': 'Vibration and Shotblocker Use in Pregnant Women While Giving Tetanus + Diphtheria Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Investigation of the Effect of Local Mechanical Vibration and Shotblocker Application on Pain and Patient Satisfaction Before Tetanus + Diphtheria Vaccine in Pregnant Women', 'orgStudyIdInfo': {'id': 'HKU-SBF-SA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Local mechanical vibration applied group', 'description': 'Before the injection, local mechanical vibration will be applied for 3 minutes with a vibration device to the deltoid muscle where the injection will be made, and then the vaccine will be given. The vibration device to be used is suitable for contact with the skin and provides 6000 rotations per minute with vibration.\n\nPregnant women who were asked to receive tetanus+diphtheria vaccine by their physician and agreed to participate in the study will be informed about the research by the researcher, and their written and verbal consents will be obtained. Then the vaccine will be administered. Td vaccine will be administered to all pregnant women in the study as IM to the deltoid muscle in the arm they do not use dominantly. Five minutes after the vaccination, the individual descriptor form will be applied to all pregnant women, and the pregnant women will score their satisfaction levels with regard to pain and the method used.', 'interventionNames': ['Other: Local mechanical vibration']}, {'type': 'EXPERIMENTAL', 'label': 'Shotblocker group', 'description': 'It is a U-shaped device with skin contact points on the shotblocker and an opening in the middle for injecting. The Shotblocker will be placed on the skin surface just before inserting the needle and gently pressed with the fingertips, and the vaccine will be administered immediately afterwards. After removing the needle, the shotblocker will be removed.\n\nPregnant women who were asked to receive tetanus+diphtheria vaccine by their physician and agreed to participate in the study will be informed about the research by the researcher, and their written and verbal consents will be obtained. Then the vaccine will be administered. Td vaccine will be administered to all pregnant women in the study as IM to the deltoid muscle in the arm they do not use dominantly. Five minutes after the vaccination, the individual descriptor form will be applied to all pregnant women, and the pregnant women will score their satisfaction levels with regard to pain and the method used.', 'interventionNames': ['Other: Shotblocker group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The vaccine will be administered by following the standard intramuscular injection procedure. Five minutes after vaccination, an individual descriptive form will be applied to all pregnant women, and pregnant women will score their pain and satisfaction levels with scales.\n\nPregnant women who were asked to receive tetanus+diphtheria vaccine by their physician and agreed to participate in the study will be informed about the research by the researcher, and their written and verbal consents will be obtained. Then the vaccine will be administered. Td vaccine will be administered to all pregnant women in the study as IM to the deltoid muscle in the arm they do not use dominantly. Five minutes after the vaccination, the individual descriptor form will be applied to all pregnant women, and the pregnant women will score their satisfaction levels with regard to pain and the method used.'}], 'interventions': [{'name': 'Local mechanical vibration', 'type': 'OTHER', 'description': 'Before the injection, local mechanical vibration will be applied for 3 minutes with a vibration device to the deltoid muscle where the injection will be made, and then the vaccine will be given. The vibration device to be used is suitable for contact with the skin and provides 6000 rotations per minute with vibration.', 'armGroupLabels': ['Local mechanical vibration applied group']}, {'name': 'Shotblocker group', 'type': 'OTHER', 'description': 'It is a U-shaped device with skin contact points on the shotblocker and an opening in the middle for injection (Tugrul, Celik, and Khorshid 2017). The Shotblocker will be placed on the skin surface just before inserting the needle and gently pressed with the fingertips, and the vaccine will be administered immediately afterwards. After removing the needle, the shotblocker will be removed.', 'armGroupLabels': ['Shotblocker group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, Doktora Öğrencisi', 'investigatorFullName': 'Senem Andı', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}