[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655538":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":41,"studyPopulation":41,"armGroups":44,"interventions":51,"overallOfficials":57,"centralContacts":61,"locations":69,"responsibleParty":84,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":41,"studyType":106,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":118,"whyStopped":41,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University Children's Hospital, Zurich","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":32},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Qualitative assessment of feasibility of the single-session intervention","Semi-structured interviews will be conducted with the patient and one of their caregivers after surgery via zoom. Interviews will be audio-recorded and transcribed for analysis. These qualitative interviews will allow for an in-depth exploration of user experiences, barriers, facilitators, and perceived usefulness of the intervention.","3-4 weeks after the surgery.",{"measure":14,"description":11,"timeFrame":15},"Qualitative assessment of the usability of the single session intervention","3-4 weeks after the surgery",{"measure":17,"description":11,"timeFrame":15},"Qualitative assessment of the acceptability of the single-session intervention",[19,23,26,29],{"measure":20,"description":21,"timeFrame":22},"Quantitative assessment of feasibility of the single-session intervention","Secondary endpoints include the quantitative assessment of feasibility using the German version of the Feasibility of Intervention Measure (FIM) This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. The FIM has demonstrated strong content validity, reliability, and responsiveness to change. All items are rated on a 5-point Likert scale ranging from \"1 - completely disagree\" to \"5 - completely agree\". For descriptive interpretation, responses of 4 (\"agree\") and 5 (\"completely agree\") will be considered indicative of a positive evaluation.","3 to 4 weeks after surgery",{"measure":24,"description":25,"timeFrame":22},"Quantitative assessment of usability of the single-session intervention","Secondary endpoints include the quantitative assessment of usability using the German version of the System Usability Scale (SUS). This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. All items are rated on a 5-point Likert scale ranging from \"1 - completely disagree\" to \"5 - completely agree\". For descriptive interpretation, responses of 4 (\"agree\") and 5 (\"completely agree\") will be considered indicative of a positive evaluation.",{"measure":27,"description":28,"timeFrame":22},"Quantitative assessment of acceptability of the single-session intervention","Secondary endpoints include the quantitative assessment of acceptability using the German version of the Acceptability of Intervention Measure (AIM). This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. The AIM has demonstrated strong content validity, reliability, and responsiveness to change. All items are rated on a 5-point Likert scale ranging from \"1 - completely disagree\" to \"5 - completely agree\". For descriptive interpretation, responses of 4 (\"agree\") and 5 (\"completely agree\") will be considered indicative of a positive evaluation.",{"measure":30,"description":31,"timeFrame":22},"Quantitative assessment of appropriateness of the single-session intervention","Secondary endpoints include the quantitative assessment of appropriateness using the German version of the Intervention Appropriateness Measure (IAM). This questionnaire will be administered digitally approximately two to three weeks after surgery, prior to the qualitative interview. The IAM have demonstrated strong content validity, reliability, and responsiveness to change. All items are rated on a 5-point Likert scale ranging from \"1 - completely disagree\" to \"5 - completely agree\". For descriptive interpretation, responses of 4 (\"agree\") and 5 (\"completely agree\") will be considered indicative of a positive evaluation.\n\nAdditional secondary endpoints include the proportion of participants with at least one use of the application before surgery and at least one use after surgery.",[33],{"measure":34,"description":35,"timeFrame":15},"Use of the application of the single-session intervention","Additional secondary endpoints include the proportion of participants with at least one use of the application before surgery and at least one use after surgery.",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":41,"timePerspective":41,"maskingInfo":42},"NA","SINGLE_GROUP","This is a pilot study assessing feasibility, usability, and acceptability of a new digital intervention.","PREVENTION",null,{"masking":43,"maskingDescription":41,"whoMasked":41},"NONE",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"Single-session psychoeducational intervention","EXPERIMENTAL","Participants will receive access to a digital single-session intervention that provides them with pain education, resources in the hospital, a personal action plan, and information for parents on how to best support their children.",[50],"Behavioral: Psychoeducational single-session intervention for families during the perioperative period",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":41},"BEHAVIORAL","Psychoeducational single-session intervention for families during the perioperative period","The intervention is digital, and there is a separate version for youth with a planned surgery and for their parents.\n\nThe intervention contains four main components:\n\n1. Psychoeducation on pain and pain management, information concerning hospitalization, general information about anesthesia and surgery, and coping strategies.\n2. Peer testimonials in the form of brief supportive statements (written\u002Faudio) from former patients and caregivers describing strategies and experiences they found helpful during the perioperative period.\n3. Activity section for participants, where they select and rank coping strategies and supportive tips from a list.\n4. Action plan based on the activites selected (see step 3) that are automatically transferred into a personalized action plan section. Participants may also add more strategies and a preferred support contact person to contact in emotionally challenging situations.",[46],[58],{"name":59,"affiliation":5,"role":60},"Helen Koechlin, PhD","PRINCIPAL_INVESTIGATOR",[62,66],{"name":59,"role":63,"phone":64,"phoneExt":41,"email":65},"CONTACT","+4144 249 63 08","helen.koechlin@uzh.ch",{"name":67,"role":63,"phone":41,"phoneExt":41,"email":68},"Patrizia Steiner, MD","patrizia.steiner@kispi.uzh.ch",[70],{"facility":71,"status":41,"city":72,"state":41,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University Children's Hospital Zurich","Zurich","8008","Switzerland","CH",{"type":77,"coordinates":78},"Point",[79,80],8.55,47.36667,{"lat":80,"lon":79},[83],{"name":59,"role":63,"phone":64,"phoneExt":41,"email":65},{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Helen Koechlin","Research Group Leader",[89,90],{"name":5,"class":6},{"name":91,"class":6},"University Children's Hospital Basel","100655538","a-short-digital-intervention-for-youth-undergoing-major-surgery-and-their-parents-100655538",false,"NCT07812961","A Short Digital Intervention for Youth Undergoing Major Surgery and Their Parents","Pediatric Perioperative Pain Intervention (POPI): A Pilot Feasibility Study of a Psychoeducational Digital Single-Session Intervention","POPI","Inclusion Criteria:\n\n* the patient is between 8 and 18 years of age;\n* the patient has a scheduled orthopedic surgery requiring inpatient care for at least one night at one of the participating hospitals;\n* the patient and at least one parent\u002Fcaregiver are able to read and understand German;\n* both the patient and the parent\u002Fcaregiver agree to participate in the study and to test the digital single-session intervention.\n\nExclusion Criteria:\n\n* the patient has a serious comorbid medical condition that may substantially affect perioperative recovery or study participation (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication);\n* the patient has undergone previous major orthopedic surgery (e.g., prior spine surgery);\n* the patient or caregiver is unable to follow study procedures due to cognitive, psychological, or language-related difficulties;\n* either the patient or one of the parents\u002Fcaregivers declines participation in the study or declines testing of the intervention.","ALL","8 Years","18 Years",{"count":104,"type":105},12,"ESTIMATED","INTERVENTIONAL",[37],"The perioperative time, i.e., the time before, during, and directly after surgery, can be stressful for families whose child needs to undergo major orthopedic surgery. Families have expressed their need for more and easily accessible information on what to expect before and after surgery, and how to deal with postoperative pain.\n\nSingle-session interventions are short interventions, often digital, that are scalable and present as a low-threshold approach for psychoeducational purposes. Previous studies have demonstrated good feasibility and acceptability of single-session interventions for psychosocial problems such as perioperative anxiety among families.\n\nTherefore, in this pilot study, the investigators will test a newly developed digital single-session intervention for youth undergoing major orthopedic surgery and their parents. The intervention will provide pain education, general and individual resources, and a special module for parents on how they can best support their children. In this study, the investigators will evaluate if participants use the digital intervention, if they perceive the content as useful and the format as engaging, and whether there are aspects that need to be added or changed.",[110],"Pediatric Orthopedic Surgery",[112,113,114,115,116,117],"children and adolescents","parents","pain education","perioperative period","single-session intervention","pilot study","NOT_YET_RECRUITING","2026-09-04",{"date":121,"type":122},"2026-09-10","ACTUAL",{"date":124,"type":105},"2026-10",{"date":126,"type":105},"2027-01",{"name":86,"class":6},1]