[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591146":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":12,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":12,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":12,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Celal Bayar University","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","The injection is administered using the standard method.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Helfer Skin Tap Tecnique","EXPERIMENTAL","After identifying the injection site, the muscles are relaxed by gently tapping the skin with the fingertips of the dominant hand for about five seconds. Using the thumb and index finger of the non-dominant hand, a V shape is formed, and the entire hand is used to tap the skin three times. Simultaneously with the third tap, the needle is inserted into the muscle at a 90-degree angle. After aspiration, the medication is injected over 5 seconds while continuing to gently tap the skin with the fingertips of the non-dominant hand. After administering the medication, the needle is withdrawn from the muscle simultaneously with final tap, while tapping the skin in a V shape using the non-dominant hand.",[18],"Behavioral: Helfer Skin Tap Tecnique",{"label":20,"type":15,"description":21,"interventionNames":22},"Local Cold Application","A cold gel compress is removed from the freezer and left at room temperature for a few minutes to thaw slightly. After identifying the injection site, the cold gel compress is wrapped in gauze and placed on the deltoid area to cover the injection site. The cold gel compress is held in place for one minute. After one minute, the cold gel compress is removed. The skin is cleaned with an alcohol swab, then the injection is administered.",[23],"Behavioral: Local Cold Application",[25,29],{"type":26,"name":14,"description":27,"armGroupLabels":28,"otherNames":12},"BEHAVIORAL","In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the \"Individual Identification Form\" will be completed.\n\nIn the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Following this, tetanus vaccination will be administered to the pregnant women in the intervention group using the Helfer Skin Tap technique in accordance with the \"Helfer Skin Tap IM Injection Procedure Guideline\".\n\nIn the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by the nurse, and the vital signs of the pregnant women will be measured again. To evaluate the long-term effects of pain, participants will be contacted via a link, and pain assessments will be conducted at the 24th and 48th hours following the vaccination.",[14],{"type":26,"name":20,"description":30,"armGroupLabels":31,"otherNames":12},"In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the \"Individual Identification Form\" will be completed.\n\nIn the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Subsequently, tetanus vaccination will be administered to the pregnant women in the intervention group using a cold compress gel, based on the \"Cold Compress Gel IM Injection Procedure Guideline\" developed in line with the relevant literature.\n\nIn the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by nurse, and the vital signs of the pregnant women will be measured again. Pain assessment will be repeated at the 24th and 48th hours following the vaccination.",[20],[33],{"name":34,"affiliation":5,"role":35},"Sevgi Pakiş Çetin, Asst. Prof.","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":12,"email":41},"Sevgi PAKİŞ ÇETİN, Asst. Prof.","CONTACT","+90 (236) 233 71 69","sevgi.pakiscetin@cbu.edu.tr",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":12,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Manisa Celal Bayar University","RECRUITING","Manisa","Uncubozköy\u002FYunusemre","45030","Turkey (Türkiye)",{"type":51,"coordinates":52},"Point",[53,54],27.42647,38.61202,{"lat":54,"lon":53},[57,58],{"name":38,"role":39,"phone":12,"phoneExt":12,"email":41},{"name":34,"role":35,"phone":12,"phoneExt":12,"email":12},{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Sevgi Çetin","Asst. Prof.","100591146","effect-of-helfer-skin-tap-and-cold-application-on-pain-and-hemodynamics-during-vaccination-100591146",false,"NCT06976632","Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination","Comparison of the Effects of the Helfer Skin Tap Technique and Local Cold Application on Pain and Hemodynamic Parameters During Vaccination in Pregnant Women","Inclusion Criteria: Pregnant women who meet the following criteria will be included in the study:\n\n* Over the age of 18,\n* Scheduled to receive a tetanus vaccine,\n* Able to speak and communicate in Turkish,\n* Willing to participate in the study,\n* Not experiencing any pain for any reason prior to the injection.\n\nExclusion Criteria: Pregnant women who meet any of the following criteria will be excluded from the study:\n\n* Under the age of 18,\n* Received a tetanus vaccine for reasons other than pregnancy,\n* Received a vaccine other than tetanus,\n* Experiencing pain for any reason prior to the vaccine,\n* Have circulatory disorders or peripheral vascular disease,\n* Have bleeding or clotting disorders,\n* Have a local infection,\n* Used painkillers at least 6 hours prior to the procedure,\n* Underwent a painful procedure within the last hour,\n* Have cold sensitivity,\n* Have cognitive or psychological issues.","FEMALE","18 Years","42 Years",{"count":73,"type":74},90,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this study is to investigate the effect of local cold application using the Helfer Skin Tap Technique on pain levels during the intramuscular injection of the tetanus vaccine in pregnant women. The study will also record vital signs, which are among the physiological effects of pain.",[80],"Pregnant Women",[82,83,84,85,86,87],"immunization","pain","hemodynamic parameters","pregnant women","local cold application","helfer skin tap tecnique","2026-03-18",{"date":90,"type":91},"2026-03-20","ACTUAL",{"date":93,"type":91},"2025-05-09",{"date":95,"type":74},"2026-06-09",{"name":5,"class":6},1]