[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624171":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":24,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":91,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Inonu University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"ShotBlocker Group","EXPERIMENTAL","Shotblocker Group: The Shotblocker device will be positioned at the gluteal injection site using aseptic techniques immediately before the administration of hormonal medications. Standard intramuscular (IM) injection protocols will be followed while the device is in situ to mitigate injection-related pain.",[13],"Device: ShotBlocker device",{"label":15,"type":16,"description":17,"interventionNames":18},"Helfer Skin Tap Technique Group","ACTIVE_COMPARATOR","Helfer Skin Tap Group: Rhythmic skin tapping will be performed at points near the gluteal injection site immediately before and during the procedure. Standard intramuscular (IM) injection of hormonal medications will be administered following the Helfer Skin Tap protocol to reduce procedural pain and muscle tension.",[19],"Procedure: This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.",{"label":21,"type":22,"description":23,"interventionNames":24},"Control Group","NO_INTERVENTION","Control Group: Standard intramuscular (IM) injection of hormonal medications will be administered to participants in this group without any supportive technique. The procedure will follow routine clinical nursing protocols.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DEVICE","ShotBlocker device","Participants in this group will receive intramuscular (IM) injections of premenopausal or postmenopausal hormonal medications. Immediately prior to the procedure, the Shotblocker device (a plastic, butterfly-shaped tool with blunt contact points) will be applied to the gluteal muscle injection site following aseptic techniques. The device will be pressed firmly against the skin to saturate the sensory signals through the gate control mechanism. While the device is in place, the IM injection will be administered according to standard clinical protocols. The device will be removed once the injection is completed and the needle is withdrawn.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":24},"PROCEDURE","This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.","Participants in this group will receive intramuscular (IM) injections of premenopausal or postmenopausal hormonal medications. Prior to and during the injection, the Helfer Skin Tap (HST) technique will be applied. This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. The tapping starts just before the needle insertion and continues rhythmically to promote muscle relaxation and utilize the gate control theory of pain management. The IM injection will be administered according to standard clinical protocols while maintaining the rhythmic tapping.",[15],[37],{"name":38,"role":39,"phone":40,"phoneExt":24,"email":41},"Zeliha Cengiz, Associate Professor","CONTACT","+905433277494","zeliha.cengiz@inonu.edu.tr",[43],{"facility":44,"status":24,"city":45,"state":46,"zip":24,"country":47,"countryCode":24,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Batman Training and Research Hospital","Batman","Center","Turkey (Türkiye)",{"type":49,"coordinates":50},"Point",[51,52],41.13221,37.88738,{"lat":52,"lon":51},[55],{"name":24,"role":39,"phone":56,"phoneExt":24,"email":57},"+90(488)2213065","batmandhs5@saglik.gov.tr",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Zeliha CENGİZ","Associate Professor","100624171","nonpharmacological-management-of-pain-and-fear-during-hormone-injection-in-breast-cancer-patients-100624171",false,"NCT07406165","Nonpharmacological Management of Pain and Fear During Hormone Injection in Breast Cancer Patients","ShotBlocker and Helfer Technique in the Management of Pain and Fear During Hormone Injection in Patients With Breast Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged between 18 and 65 years.\n* Patients diagnosed with breast cancer.\n* Requirement of intramuscular (IM) injection of premenopausal or postmenopausal hormonal medications as part of their prescribed treatment.\n* Cognitive competence to provide informed consent for the injection procedure. Intact skin integrity and normal sensory perception at the injection site (gluteal region).\n\nExclusion Criteria:\n\n* History of chronic pain disorders, neuropathic pain syndrome, or any disease requiring regular analgesic use.\n* Presence of neurological or cognitive disorders that may alter pain or fear perception.\n* Use of analgesics within the last 24 hours (or a specific timeframe relevant to your study).","ALL","18 Years","65 Years",{"count":73,"type":74},99,"ESTIMATED","INTERVENTIONAL",[77],"NA","This randomized controlled study will compare the effects of the ShotBlocker device and the Helfer Skin Tap Technique on pain and fear during intramuscular hormone injections in premenopausal and postmenopausal breast cancer patients. Ninety-nine participants will be randomly assigned to three groups (ShotBlocker, Helfer, control). All injections will be administered by the same nurse using standardized procedures. Pain will be assessed with the Visual Analog Scale, and fear with the Injection Fear Scale. The study aims to identify effective nonpharmacological methods to enhance patient comfort, support treatment adherence, and improve nursing care quality.",[80,81,82,83,84],"Breast Cancer","Pain Management","Fear","Injection Fear","Injection Pain Prevention",[86,87,88,89,90],"Breast cancer","Hormone therapy","Intramuscular injection","Pain","Injection fear","NOT_YET_RECRUITING","2026-02-11",{"date":94,"type":95},"2026-02-13","ACTUAL",{"date":97,"type":74},"2026-02-10",{"date":99,"type":74},"2026-07",{"name":5,"class":6},1]