An interventional study of Weighted Blanket and Standard Hospital Blanket in Traumatic Injury and Acute Pain, sponsored by University of Texas at Austin. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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.
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.
Eligible 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.
Study 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.
Approximately 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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Weighted Blanket
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.
Device: Standard Hospital Blanket
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.
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.
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/randomization will be averaged to calculate one average daily pain score.
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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).
Time frame: Everyday for up to the first 7 study days following enrollment/randomization, or until hospital discharge, participant withdrawal, or loss of capacity to continue participation, whichever occurs first.
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/randomization.
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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.
Time frame: From hospital admission through hospital discharge; assessed once at discharge.
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/randomization will be averaged to calculate one average daily systolic blood pressure value, reported in millimeters of mercury (mmHg).
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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/randomization will be averaged to calculate one average daily diastolic blood pressure value, reported in millimeters of mercury (mmHg).
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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/randomization will be averaged to calculate one average daily heart rate value, reported in beats per minute (beats/min).
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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/randomization will be averaged to calculate one average daily temperature value, reported in degrees Fahrenheit (°F).
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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/randomization will be averaged to calculate one average daily respiratory rate value, reported in breaths per minute (breaths/min).
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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.
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
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/throughout the day. Responses will be summarized by category.
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
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.
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
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.
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
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.
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 5 months is below that.
Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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