[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654579":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":64,"studyPopulation":56,"armGroups":65,"interventions":78,"overallOfficials":86,"centralContacts":91,"locations":101,"responsibleParty":119,"collaborators":56,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":56,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":56,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":145,"whyStopped":56,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Pain Intensity","Pain intensity will be assessed using routinely documented Numeric Pain Rating Scale (NPRS) scores collected from the electronic medical record as part of standard clinical care, typically every 6 to 8 hours. The NPRS ranges from 0 to 10, with higher scores indicating greater pain intensity. For each participant, all available NPRS scores within each 24-hour study period following enrollment\u002Frandomization will be averaged to calculate one average daily pain score.","Each 24-hour study period from enrollment\u002Frandomization through hospital discharge or 7 days whichever comes first",[14,18,21,25,28,31,34,37,40,44,47,50,53],{"measure":15,"description":16,"timeFrame":17},"Anxiety","Anxiety will be assessed daily using the Anxiety Visual Analog Scale (VAS), a 100-millimeter horizontal line anchored by \"Not at all anxious\" (0 mm) on the left and \"Extremely anxious\" (100 mm) on the right. Scores range from 0 to 100 mm, with higher scores indicating greater anxiety (a worse outcome).","Everyday for up to the first 7 study days following enrollment\u002Frandomization, or until hospital discharge, participant withdrawal, or loss of capacity to continue participation, whichever occurs first.",{"measure":19,"description":20,"timeFrame":12},"Opioid Utilization","Opioid utilization will be calculated as daily morphine milligram equivalents (MME) using opioid medications documented in the electronic medical record. For each participant, daily MME will be calculated for each available 24-hour study period following enrollment\u002Frandomization.",{"measure":22,"description":23,"timeFrame":24},"Length of Hospital Stay","Total inpatient hospital length of stay will be calculated from the date of hospital admission through the date of hospital discharge using data obtained from the electronic medical record and reported in days.","From hospital admission through hospital discharge; assessed once at discharge.",{"measure":26,"description":27,"timeFrame":12},"Average Daily Systolic Blood Pressure","Systolic blood pressure measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available systolic blood pressure measurements within each 24-hour study period following enrollment\u002Frandomization will be averaged to calculate one average daily systolic blood pressure value, reported in millimeters of mercury (mmHg).",{"measure":29,"description":30,"timeFrame":12},"Average Daily Diastolic Blood Pressure","Diastolic blood pressure measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available diastolic blood pressure measurements within each 24-hour study period following enrollment\u002Frandomization will be averaged to calculate one average daily diastolic blood pressure value, reported in millimeters of mercury (mmHg).",{"measure":32,"description":33,"timeFrame":12},"Average Daily Heart Rate","Heart rate measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available heart rate measurements within each 24-hour study period following enrollment\u002Frandomization will be averaged to calculate one average daily heart rate value, reported in beats per minute (beats\u002Fmin).",{"measure":35,"description":36,"timeFrame":12},"Average Daily Temperature","Temperature measurements documented in the electronic medical record as part of standard clinical care will be collected. Temperature values documented in degrees Celsius will be converted to degrees Fahrenheit prior to analysis. For each participant, all available temperature measurements within each 24-hour study period following enrollment\u002Frandomization will be averaged to calculate one average daily temperature value, reported in degrees Fahrenheit (°F).",{"measure":38,"description":39,"timeFrame":12},"Average Daily Respiratory Rate","Respiratory rate measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available respiratory rate measurements within each 24-hour study period following enrollment\u002Frandomization will be averaged to calculate one average daily respiratory rate value, reported in breaths per minute (breaths\u002Fmin).",{"measure":41,"description":42,"timeFrame":43},"Blanket Use Frequency","Participants will report how often they used the blanket during the hospital stay using a 5-category ordinal response scale: Never, Rarely, Sometimes, Often, or Always. Responses will be summarized by category.","Once, on the day of hospital discharge or within 24 hours prior to discharge.",{"measure":45,"description":46,"timeFrame":43},"Typical Duration of Blanket Use","Participants will report the typical duration of blanket use on days when the blanket was used. Response categories are: Not applicable - did not use the blanket; Less than 30 minutes; 30 minutes to 1 hour; 1 to 2 hours; More than 2 hours but not overnight; or Overnight\u002Fthroughout the day. Responses will be summarized by category.",{"measure":48,"description":49,"timeFrame":43},"Reasons for Not Using the Blanket","Participants who chose not to use the blanket at any point will be asked to select one or more reasons. Response options consist of: blanket was too heavy, too warm, uncomfortable on the injury, participant did not feel it was needed, participant forgot it was available, or other (please list the reason). The number and percentage of participants selecting each reason will be reported.",{"measure":51,"description":52,"timeFrame":43},"Overall Blanket Satisfaction","Participants will rate their overall satisfaction with the blanket using a 5-point ordinal satisfaction scale ranging from Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied. Responses will be coded from 1 to 5, with higher scores indicating greater satisfaction and therefore a better outcome.",{"measure":54,"description":55,"timeFrame":43},"Preference for Future Blanket Availability","Participants will indicate whether they would want a blanket available during a future hospital stay using a 5-point ordinal response scale: Definitely not, Probably not, Unsure, Probably yes, or Definitely yes. Responses will be coded from 1 to 5, with higher scores indicating a greater preference for future blanket availability.",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":60,"primaryPurpose":61,"observationalModel":56,"timePerspective":56,"maskingInfo":62},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to receive either a commercially available weighted blanket or the standard hospital blanket routinely provided during hospitalization. Assigned blankets will be provided according to randomized group assignment, and participants may use or discontinue use of the assigned blanket at their discretion.","TREATMENT",{"masking":63,"maskingDescription":56,"whoMasked":56},"NONE","This study is a prospective, single-center, randomized controlled trial evaluating weighted blanket use as a non-pharmacologic intervention for adult trauma inpatients admitted to Dell Seton Medical Center.\n\nEligible participants who provide written informed consent will be randomized in a 1:1 ratio to receive either a commercially available weighted blanket or the standard hospital blanket routinely provided during hospitalization. Participants in both groups will otherwise receive routine clinical care. Assigned blankets will be provided according to randomized group assignment, and participants may use or discontinue use of their assigned blanket at their discretion.\n\nStudy data will be collected through review of the electronic medical record and participant-reported assessments. Pain outcomes will be evaluated using Numeric Pain Rating Scale (NPRS) scores documented as part of routine clinical care. Anxiety will be assessed using a daily Visual Analog Scale (VAS) during the first seven study days following enrollment or until hospital discharge, whichever occurs first. Additional study measures include opioid utilization, vital signs, length of hospital stay, and participant-reported blanket use and satisfaction.\n\nApproximately 50 participants are expected to be enrolled. Study data will be analyzed to compare outcomes between the study groups and evaluate weighted blanket use as a non-pharmacologic adjunct to pain and anxiety management in adult trauma inpatients.",[66,72],{"label":67,"type":68,"description":69,"interventionNames":70},"Weighted Blanket","EXPERIMENTAL","Participants randomized to this arm will receive a commercially available weighted blanket during hospitalization. Participants will otherwise receive routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time. The weighted blanket is considered investigational for this study purpose and is being evaluated for its effect on pain and anxiety in trauma inpatients.",[71],"Device: Weighted Blanket",{"label":73,"type":74,"description":75,"interventionNames":76},"Standard Hospital Blanket","ACTIVE_COMPARATOR","Participants randomized to this arm will receive the standard hospital blanket routinely provided during hospitalization. Participants will otherwise receive routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time. Blankets are laundered and reused according to routine hospital practice.",[77],"Device: Standard Hospital Blanket",[79,83],{"type":80,"name":67,"description":81,"armGroupLabels":82,"otherNames":56},"DEVICE","A commercially available weighted blanket provided by the study for use during hospitalization as a non-pharmacologic adjunct to routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time.",[67],{"type":80,"name":73,"description":84,"armGroupLabels":85,"otherNames":56},"The standard hospital blanket routinely provided during hospitalization and used as the comparator to the weighted blanket. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time.",[73],[87],{"name":88,"affiliation":89,"role":90},"Carlos Brown, MD","The University of Texas at Austin","PRINCIPAL_INVESTIGATOR",[92,96],{"name":88,"role":93,"phone":94,"phoneExt":56,"email":95},"CONTACT","5123247776","carlos.brown@austin.utexas.edu",{"name":97,"role":93,"phone":98,"phoneExt":99,"email":100},"Sadia Ali, MPH","5123247000","48919","sali2@ascension.org",[102],{"facility":103,"status":56,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Dell Seton Medical Center at The University of Texas","Austin","Texas","78701","United States","US",{"type":110,"coordinates":111},"Point",[112,113],-97.74306,30.26715,{"lat":113,"lon":112},[116,117,118],{"name":88,"role":93,"phone":94,"phoneExt":56,"email":95},{"name":97,"role":93,"phone":98,"phoneExt":99,"email":100},{"name":88,"role":90,"phone":56,"phoneExt":56,"email":56},{"type":90,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Carlos Brown","Professor, Department of Surgery and Perioperative Care","100654579","weighted-blankets-for-pain-and-anxiety-in-adult-trauma-patients-100654579",false,"NCT07802171","Weighted Blankets for Pain and Anxiety in Adult Trauma Patients","The Impact of Weighted Blanket Administration for Acute Pain in Trauma Inpatients","Inclusion Criteria\n\n* Adults aged 18 to 89 years\n* Patients admitted to the trauma service at Dell Seton Medical Center\n* Glasgow Coma Scale (GCS) score of 15 at the time of enrollment\n* Able to provide informed consent and participate in study assessments\n* Medically stable for participation, as documented in the electronic medical record and\u002For confirmed by the treating clinical team\n\nExclusion Criteria\n\n* Age younger than 18 years\n* Age older than 89 years\n* Pregnant patients\n* Intubated or mechanically ventilated patients\n* Patients with burn injuries\n* Prisoners or incarcerated individuals","ALL","18 Years","89 Years",{"count":133,"type":134},50,"ESTIMATED","INTERVENTIONAL",[137],"NA","The purpose of this study is to determine whether the use of a weighted blanket improves pain and anxiety among adult trauma inpatients. Participants will be randomly assigned to receive either a weighted blanket or the standard hospital blanket routinely provided during hospitalization. Pain scores documented as part of routine clinical care and participant-reported anxiety ratings will be compared between groups. This study will evaluate whether weighted blankets may serve as a non-pharmacologic adjunct to pain and anxiety management for adult trauma inpatients.",[140,141],"Traumatic Injury","Acute Pain",[67,15,143,144],"Pain Management","Trauma","NOT_YET_RECRUITING","2026-09-01",{"date":148,"type":149},"2026-09-03","ACTUAL",{"date":151,"type":134},"2026-09",{"date":153,"type":134},"2027-02",{"name":5,"class":6},1]