[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658639":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":13,"overallOfficials":13,"centralContacts":13,"locations":19,"responsibleParty":41,"collaborators":13,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":13,"enrollmentInfo":54,"targetDuration":13,"studyType":57,"phases":13,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":13,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Uppsala University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Skin conductance to N-PASS score correlation","Correlation between skin conductance measurements and N-PASS scores and vital parameters during the postoperative period","72-80 hours after surgery",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Exposure to pain in the neonatal period is associated with adverse short- and long-term outcomes, including altered neurodevelopment. Accurate pain assessment is therefore essential but remains challenging due to the lack of a gold standard.\n\nCurrently, pain assessment in neonates relies on observational tools such as N-PASS, which incorporates behavioral and physiological indicators. However, these assessments are intermittent and subject to observer variability.\n\nSkin conductance monitoring is an objective and continuous method that measures sympathetic nervous system activity through electrodermal responses. Previous research has demonstrated that skin conductance can detect stress and pain responses even in extremely preterm infants.\n\nIn this study, postoperative neonates admitted to the NICU will be continuously monitored using skin conductance for approximately 72-80 hours following surgery. Routine clinical pain assessments using N-PASS will be performed at regular intervals, alongside continuous monitoring of vital parameters.\n\nAdditional clinical data will be collected from electronic medical records, including demographic characteristics, perinatal history, surgical details, postoperative recovery parameters, and analgesic treatments.\n\nThe study is purely observational, and no interventions beyond standard clinical care will be introduced.","Neonates receiving postoperative care in a tertiary neonatal intensive care unit.",[20],{"facility":5,"status":13,"city":21,"state":13,"zip":13,"country":22,"countryCode":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":30},"Uppsala","Sweden","SE",{"type":25,"coordinates":26},"Point",[27,28],17.63889,59.85882,{"lat":28,"lon":27},[31,36,39],{"name":32,"role":33,"phone":34,"phoneExt":13,"email":35},"Johanna Tidehag Walan, Medical Doctor, PhD-student","CONTACT","704184255","johanna.walan@uu.se",{"name":37,"role":33,"phone":13,"phoneExt":13,"email":38},"Richard Sindelar, Professor","richard.sindelar@uu.se",{"name":37,"role":40,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"type":40,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Johanna Tidehag Walan","MD","100658639","postoperative-pain-in-infants-100658639",false,"NCT07856615","Postoperative Pain in Infants","Assessment of Pain Using Skin Conductance Monitoring in Postoperative Neonates","Poppi","Inclusion Criteria\n\n* Neonates admitted to the NICU\n* Undergoing surgical intervention\n* Receiving postoperative care at the study site\n\nExclusion Criteria\n\n* Lack of parental consent (if applicable)\n* Major congenital conditions affecting autonomic nervous system function","ALL","22 Weeks",{"count":55,"type":56},100,"ESTIMATED","OBSERVATIONAL","This observational study aims to evaluate skin conductance measurement (SCM) for pain assessment in postoperative newborns.\n\nPain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation Scale (N-PASS) in combination with physiological parameters.\n\nSkin conductance reflects sympathetic nervous system activity and provides a continuous, objective measure of stress and pain. This study will investigate the correlation between skin conductance measurements and standard clinical pain assessment tools (N-PASS and vital parameters), as well as explore the potential analgesic effect of skin-to-skin care on postoperative pain.\n\nThe study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.",[60],"Postoperative Pain",[62,63,64,65],"skin conductance monitoring","postoperative pain","neonate","preterm infant","NOT_YET_RECRUITING","2026-09-28",{"date":69,"type":70},"2026-10-02","ACTUAL",{"date":72,"type":56},"2026-10-30",{"date":74,"type":56},"2030-02-01",{"name":5,"class":6},1]