Traumatic InjuryNCT07802171
Weighted Blankets for Pain and Anxiety in Adult Trauma Patients
A study testing Weighted Blanket and Standard Hospital Blanket in people with Traumatic Injury and Acute Pain, run by University of Texas at Austin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Injury, Acute Pain
- What is being tested?
- Weighted Blanket and Standard Hospital Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 89 years
- Patients admitted to the trauma service at Dell Seton Medical Center
- Glasgow Coma Scale (GCS) score of 15 at the time of enrollment
- Able to provide informed consent and participate in study assessments
- Medically stable for participation, as documented in the electronic medical record and/or confirmed by the treating clinical team
Who cannot join
- Age younger than 18 years
- Age older than 89 years
- Pregnant patients
- Intubated or mechanically ventilated patients
- Patients with burn injuries
- Prisoners or incarcerated individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
Carlos Brown, MD, 5123247776, carlos.brown@austin.utexas.edu
Sadia Ali, MPH, 5123247000 ext. 48919, sali2@ascension.org
About this study
Official title: The Impact of Weighted Blanket Administration for Acute Pain in Trauma Inpatients
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.
Read the detailed description
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.
- Conditions
- Traumatic Injury, Acute Pain
- Being tested
- Weighted Blanket, Standard Hospital Blanket
- Keywords
- Weighted Blanket, Anxiety, Pain Management, Trauma
- Medical subject headings
- Wounds and Injuries, Acute Pain, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketDevice
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.
Standard Hospital BlanketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Weighted Blanket |
| 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. Receives: Device: Standard Hospital Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Secondary outcomes (13)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Brown, University of Texas at Austin
- Investigators
- Carlos Brown, MD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802171
- Sponsor's protocol ID
- STUDY00009363
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Weighted Blanket Administration for Acute Pain in Trauma Inpatients
- ClinicalTrials.gov ID
- NCT07802171
- Acronym / sponsor ID
- STUDY00009363
- Conditions
- Traumatic Injury, Acute Pain
- Keywords
- Weighted Blanket, Anxiety, Pain Management, Trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Weighted Blanket | Experimental | Device: Weighted BlanketParticipants 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. |
| Standard Hospital Blanket | Active comparator | Device: Standard Hospital BlanketParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 89 years
- Patients admitted to the trauma service at Dell Seton Medical Center
- Glasgow Coma Scale (GCS) score of 15 at the time of enrollment
- Able to provide informed consent and participate in study assessments
- Medically stable for participation, as documented in the electronic medical record and/or confirmed by the treating clinical team
Key exclusion criteria (6 listed)
- Age younger than 18 years
- Age older than 89 years
- Pregnant patients
- Intubated or mechanically ventilated patients
- Patients with burn injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted BlanketA 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. | Device | Weighted Blanket |
| Standard Hospital BlanketThe 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. | Device | Standard Hospital Blanket |
Primary outcome
Pain Intensity
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
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.
13 secondary outcomes
Anxiety
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
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Length of Hospital Stay
Time frame: From hospital admission through hospital discharge; assessed once at discharge.
Average Daily Systolic Blood Pressure
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Average Daily Diastolic Blood Pressure
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Average Daily Heart Rate
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Average Daily Temperature
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Average Daily Respiratory Rate
Time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Blanket Use Frequency
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Typical Duration of Blanket Use
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Reasons for Not Using the Blanket
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Overall Blanket Satisfaction
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Preference for Future Blanket Availability
Time frame: Once, on the day of hospital discharge or within 24 hours prior to discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Brown, MD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket and Standard Hospital Blanket in people with Traumatic Injury and Acute Pain, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Brown, MD (5123247776, carlos.brown@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.