[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657334":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":57,"overallOfficials":37,"centralContacts":37,"locations":37,"responsibleParty":64,"collaborators":37,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":37,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":37,"enrollmentInfo":75,"targetDuration":37,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":37,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":37},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Peak procedural pain intensity","Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. The peak pain score recorded during the painful procedure will be compared between the stress-ball distraction and standard-care groups.","During the painful procedure",[14,17,21,25,28,31,34],{"measure":15,"description":16,"timeFrame":12},"State anxiety during the painful procedure","State anxiety will be assessed using the six-item State-Trait Anxiety Inventory (STAI-6). Each item is scored from 1 to 4, with total scores ranging from 6 to 24; higher scores indicate greater anxiety. Anxiety will be compared between the stress-ball distraction group and the usual-care control group.",{"measure":18,"description":19,"timeFrame":20},"Patient satisfaction with the procedure and pain management","Patient satisfaction will be assessed using a 5-point Likert satisfaction scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction with pain management and the overall procedural experience.","15 minutes after the painful procedure",{"measure":22,"description":23,"timeFrame":24},"Heart rate during and after the painful procedure","Heart rate (beats per minute) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.","Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)",{"measure":26,"description":27,"timeFrame":24},"Systolic blood pressure during and after the painful procedure","Systolic blood pressure (mmHg) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.",{"measure":29,"description":30,"timeFrame":24},"Diastolic blood pressure during and after the painful procedure","Diastolic blood pressure (mmHg) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.",{"measure":32,"description":33,"timeFrame":24},"Respiratory rate during and after the painful procedure","Respiratory rate (breaths per minute) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.",{"measure":35,"description":36,"timeFrame":24},"Peripheral oxygen saturation (SpO₂) during and after the painful procedure","Peripheral oxygen saturation (SpO₂, %) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Standard care","ACTIVE_COMPARATOR","Participants will receive the usual standard care provided during the painful procedure, without stress-ball distraction.",[50],"Other: Standard care",{"label":52,"type":53,"description":54,"interventionNames":55},"Stress-Ball Distraction","EXPERIMENTAL","Participants will receive standard care during the painful procedure and will use a hand-held stress ball as a distraction technique.",[56],"Other: Stress-Ball Distraction",[58,61],{"type":6,"name":52,"description":59,"armGroupLabels":60,"otherNames":37},"Participants assigned to the experimental arm will use a hand-held stress ball as a non-pharmacological distraction technique during the painful procedure, in addition to receiving standard care.",[52],{"type":6,"name":46,"description":62,"armGroupLabels":63,"otherNames":37},"Participants will receive the routine standard care provided during the painful procedure according to the unit's usual clinical practice. No stress-ball distraction technique will be provided.",[46],{"type":65,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100657334","stress-ball-distraction-for-pain-and-anxiety-during-painful-procedures-in-critically-ill-patients-100657334",false,"NCT07836842","Stress-Ball Distraction for Pain and Anxiety During Painful Procedures in Critically Ill Patients","The Effect of Stress-Ball Distraction on Pain, Anxiety, Physiologic Responses, and Satisfaction During Painful Procedures in Critically Ill Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged ≥18 years admitted to the critical care unit.\n* Patients scheduled for a painful procedure, including arterial puncture, venipuncture, tracheal suctioning, repositioning, or dressing change.\n* Patients able to provide informed consent.\n* Patients able to use the pain and anxiety rating scales.\n\nExclusion Criteria:\n\n* Cognitive impairment preventing reliable self-report.\n* Severe hand injury or neuromuscular disorder.\n* Hemodynamic instability.\n* Allergy to stress-ball materials.","ALL","18 Years",{"count":76,"type":77},104,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study will examine whether using a small hand-held stress ball during painful procedures can help critically ill adult patients feel less pain and anxiety. Painful procedures may also temporarily increase heart rate, blood pressure, and breathing rate.\n\nParticipants will be randomly assigned, like flipping a coin, to one of two groups. One group will receive usual care during the procedure. The other group will receive usual care and will be asked to squeeze a stress ball as a distraction technique during the procedure.\n\nThe study team will measure participants' pain and anxiety before, during, and 15 minutes after the procedure. The team will also record heart rate, blood pressure, respiratory rate, oxygen saturation, procedure-related events, use of additional pain medicine or sedation, and satisfaction with care. The findings may help health care providers understand whether stress-ball distraction is a safe, simple, non-drug method for improving comfort during painful procedures in critically ill patients.",[83],"Procedural Pain",[85,86,87],"procedural pain","Critical illness","Anxiety","NOT_YET_RECRUITING","2026-09-17",{"date":91,"type":92},"2026-09-23","ACTUAL",{"date":94,"type":77},"2026-09-30",{"date":96,"type":77},"2027-01-01",{"name":5,"class":6}]