[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"injection-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:injection-pain":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100652822","cold-spray-and-helfer-skin-tap-for-pain-during-infant-vaccination-100652822",false,"NCT07779681","Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination","The Effect of Cold Spray and Helfer Skin Tap Technique Used in Intramuscular Vaccinatıon on Pain Levels","Inclusion Criteria:\n\n* Parent or legal guardian has at least primary school education.\n* Parent or legal guardian agrees for the infant to participate in the study.\n* The infant is scheduled to receive the pneumococcal conjugate vaccine by - intramuscular injection.\n* The infant was born between 38 and 42 weeks of gestation.\n* The infant is 12 months old.\n* The infant's body weight corresponds to the 50th percentile.\n\nExclusion Criteria:\n\n* Parent or legal guardian is illiterate.\n* The infant was born preterm or postterm.\n* The infant attends the family health center for a vaccine other than the pneumococcal conjugate vaccine.\n* The infant has a congenital anomaly, birth asphyxia, or any chronic disease.\n* The infant received an analgesic medication within at least 4 hours before vaccination.",true,"ALL","12 Months",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled experimental study aims to evaluate the effects of cold spray and the Helfer Skin Tap technique on pain levels during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants.\n\nVaccination is one of the most common painful procedures during infancy. Pain experienced during injections may cause distress in infants and anxiety in families. Therefore, simple, safe, non-pharmacological methods that can reduce injection-related pain are important in pediatric nursing and primary health care.\n\nThe study will be conducted at Çorum Söğütlüevler Family Health Center between March 2026 and March 2027. The study population will consist of 12-month-old infants who attend the family health center for intramuscular pneumococcal conjugate vaccination. A total of 120 infants are planned to be included in the study. Participants will be assigned to one of three groups by stratified block randomization: cold spray group, Helfer Skin Tap group, or control group. Each group will include 40 infants.\n\nInfants in the control group will receive routine vaccination without any additional intervention. In the cold spray group, cold spray will be applied to the injection site before vaccination. In the Helfer Skin Tap group, the technique will be applied before and during the injection by gently tapping near the injection site in coordination with needle insertion.\n\nData will be collected using a Child Information Form, an Application Record Form, and the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC). Pain responses will be evaluated before, during, and after vaccination. Crying duration and physiological parameters such as pulse, oxygen saturation, and body temperature will also be recorded.\n\nThe findings of this study are expected to contribute to evidence-based pediatric nursing practices by identifying whether cold spray or the Helfer Skin Tap technique is effective in reducing pain during infant vaccination.",[27,28,29],"Procedural Pain","Vaccination Pain","Injection Pain",[31,32,33,34,35],"Cold spray","Helfer Skin Tap","Infant","Procedural pain","Vaccination","NOT_YET_RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-21","ACTUAL",{"date":42,"type":21},"2026-09-15",{"date":44,"type":21},"2027-09-01",{"name":46,"class":47},"Hitit University","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100580193","impact-of-pain-from-injectables-antiretroviral-treatments-in-hiv-1-patients-based-on-the-injection-site-ventrogluteal-or-dorsogluteal-and-the-use-or-non-use-of-virtual-reality-headset-100580193","NCT06834113","Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset","Impact of Two Types of Interventions (Ventrogluteal Versus Dorsogluteal Injection Site; Virtual Reality Headset: Presence or Absence) on Pain After Injections of Vocabria® (Cabotegravir) and Rekambys® (Rilpivirine) in Patients Infected With Human Immunodeficiency Virus -1","VIHINJECT","Inclusion Criteria:\n\n* Patient aged at least 18 years;\n* Patient infected with HIV-1;\n* Patient virologically controlled (VL \\\u003C 50 copies\u002Fml);\n* Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician.\n\nExclusion Criteria:\n\n* Patient(s) on another injectable antiretroviral treatment;\n* Patient participating in another clinical trial with medication;\n* Patient(s) with epilepsy;\n* Patient on antidepressant treatment;\n* Patient(s) with psychiatric or behavioral disorders;\n* Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset;\n* Patient(s) with visual and hearing impairments that prevent the use of virtual reality headset;\n* Patient(s) deprived of liberty, under guardianship or under curatorship;\n* Patient(s) not affiliated with a social security scheme;\n* Pregnant or breastfeeding women.","18 Years",{"count":20,"type":21},[24],"This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset.\n\nParticipants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D).\n\nEach patient will be their own witness and will experience the 4 intramuscular injection procedures of injectable antiretroviral.\n\nThe study population are patients carrying HIV-1 and being monitored for this pathology, eligible (naïve patients) or already under Cabotegravir® (CAB) and Rilpivirine® (RPV) injectable treatment.",[61,29],"HIV I Infection","RECRUITING","2025-12-22",{"date":65,"type":40},"2025-12-30",{"date":67,"type":40},"2025-01-24",{"date":69,"type":21},"2026-09-24",{"name":71,"class":47},"Centre Hospitalier Régional d'Orléans",5]